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Effect on Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Ethinyl estradiol, Levonorgestrel (Miranova)

Placebo Match to SH T00658ID

Placebo Match to SH D593B

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary Dysmenorrhea, Oral Contraception

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.

Exclusion Criteria:

Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
Obesity: body mass index (BMI) > 32 kg/m2
Hypersensitivity to any of the study drug ingredients
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
Abuse of alcohol, drugs, or medicines (e.g. laxatives)
Other contraceptive methods:
- Sterilization
- Oral, vaginal or transdermal hormonal contraception during treatment
- Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
Major surgery scheduled for the study period

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Ethinyl estradiol, Levonorgestrel (Miranova)

Arm Description

Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles

Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles

Outcomes

Primary Outcome Measures

Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain

Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

Secondary Outcome Measures

Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain

Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding

Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding

Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)

Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)

Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)

Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)

Percentage of Participants Satisfied With Study Treatment

Participants were asked to express the degree of their satisfaction with study treatment.

Number of Days With Bleeding or Spotting

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

Number of Episodes With Bleeding or Spotting

Mean Length of Bleeding or Spotting Episodes

Maximum Length of Bleeding or Spotting Episodes

Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode

Number of Days With Spotting-only

Number of Episodes With Spotting-only

Mean Length of Spotting Only Episodes

Maximum Length of Spotting Only Episodes

Difference in Duration Between Longest and Shortest Spotting Only Episode

Percentage of Participants With Withdrawal Bleeding at Cycle 1

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

Percentage of Participants With Withdrawal Bleeding at Cycle 3

Length of Withdrawal Bleeding Episodes at Cycle 1

Length of Withdrawal Bleeding Episodes at Cycle 3

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Onset of Withdrawal Bleeding Episodes at Cycle 1

Onset of Withdrawal Bleeding Episodes at Cycle 3

Percentage of Participants With Intracyclic Bleeding at Cycle 1

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

Percentage of Participants With Intracyclic Bleeding at Cycle 3

Number of Intracyclic Bleeding Episodes at Cycle 1

Number of Intracyclic Bleeding Episodes at Cycle 3

Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

Number of Intracyclic Bleeding Days at Cycle 1

Number of Intracyclic Bleeding Days at Cycle 3

Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression

The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study.

Participants With Improvement in Participants' Assessment in the Clinical Global Impression

The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study.

Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Full Information

NCT ID

NCT00909857

First Posted

April 24, 2009

Last Updated

August 6, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00909857

Brief Title

Effect on Primary Dysmenorrhea

Official Title

A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea, Oral Contraception

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

507 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Arm Type

Experimental

Arm Description

Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles

Arm Title

Ethinyl estradiol, Levonorgestrel (Miranova)

Arm Type

Active Comparator

Arm Description

Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles

Intervention Type

Drug

Intervention Name(s)

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Intervention Description

Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval

Intervention Type

Drug

Intervention Name(s)

Ethinyl estradiol, Levonorgestrel (Miranova)

Intervention Description

Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval

Intervention Type

Drug

Intervention Name(s)

Placebo Match to SH T00658ID

Intervention Description

Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Intervention Type

Drug

Intervention Name(s)

Placebo Match to SH D593B

Intervention Description

Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Primary Outcome Measure Information:

Title

Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Secondary Outcome Measure Information:

Title

Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Title

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Title

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Title

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Title

Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Title

Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Title

Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)

Description

Time Frame

baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Title

Percentage of Participants Satisfied With Study Treatment

Description

Participants were asked to express the degree of their satisfaction with study treatment.

Time Frame

From cycle 1 to cycle 3 (28 days per cycle)

Title

Number of Days With Bleeding or Spotting

Description

Time Frame

From day 1 to day 90

Title

Number of Episodes With Bleeding or Spotting

Description

Time Frame

From day 1 to day 90

Title

Mean Length of Bleeding or Spotting Episodes

Description

Time Frame

From day 1 to day 90

Title

Maximum Length of Bleeding or Spotting Episodes

Description

Time Frame

From day 1 to day 90

Title

Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode

Description

Time Frame

From day 1 to day 90

Title

Number of Days With Spotting-only

Description

Time Frame

From day 1 to day 90

Title

Number of Episodes With Spotting-only

Description

Time Frame

From day 1 to day 90

Title

Mean Length of Spotting Only Episodes

Description

Time Frame

From day 1 to day 90

Title

Maximum Length of Spotting Only Episodes

Description

Time Frame

From day 1 to day 90

Title

Difference in Duration Between Longest and Shortest Spotting Only Episode

Description

Time Frame

From day 1 to day 90

Title

Percentage of Participants With Withdrawal Bleeding at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Percentage of Participants With Withdrawal Bleeding at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Length of Withdrawal Bleeding Episodes at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Length of Withdrawal Bleeding Episodes at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Onset of Withdrawal Bleeding Episodes at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Onset of Withdrawal Bleeding Episodes at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Percentage of Participants With Intracyclic Bleeding at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Percentage of Participants With Intracyclic Bleeding at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Number of Intracyclic Bleeding Episodes at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Number of Intracyclic Bleeding Episodes at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Number of Intracyclic Bleeding Days at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Number of Intracyclic Bleeding Days at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

Description

Time Frame

At cycle 1 (28 days per cycle)

Title

Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

Description

Time Frame

At cycle 3 (28 days per cycle)

Title

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening

Description

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Time Frame

At screening (28 days)

Title

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle

Description

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Time Frame

At Baseline (28 days per cycle)

Title

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2

Description

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Time Frame

At cycle 2 (28 days per cycle)

Title

Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination

Description

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

Time Frame

At final examination (28 days)

Title

Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

Description

The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

Time Frame

At screening (average over 3 months before screening)

Title

Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression

Description

Time Frame

At cycle 2 (28 days per cycle)

Title

Participants With Improvement in Participants' Assessment in the Clinical Global Impression

Description

The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study.

Time Frame

At cycle 2 (28 days per cycle)

Title

Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

at final examination (28 days)

Title

Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

At final examination (28 days)

Title

Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

At final examination (28 days)

Title

Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

At final examination (28 days)

Title

General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

At final examination (28 days)

Title

Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

At final examination (28 days)

Title

Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

At final examination (28 days)

Title

Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

Description

Time Frame

At baseline cycle (28 days per cycle)

Title

Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

Description

Time Frame

At final examination (28 days)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit) Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1. Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study. Exclusion Criteria: Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment) Obesity: body mass index (BMI) > 32 kg/m2 Hypersensitivity to any of the study drug ingredients Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding Abuse of alcohol, drugs, or medicines (e.g. laxatives) Other contraceptive methods: Sterilization Oral, vaginal or transdermal hormonal contraception during treatment Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1 Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator Major surgery scheduled for the study period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

City

Leesburg

State/Province

Florida

ZIP/Postal Code

34748

Country

United States

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

Country

United States

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54691

Country

United States

City

Langley

State/Province

British Columbia

ZIP/Postal Code

V3A 4H9

Country

Canada

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 2T2

Country

Canada

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4P 3X1

Country

Canada

City

Santiago de Chile

Country

Chile

City

Santiago

Country

Chile

City

Talcahuano

Country

Chile

City

Temuco

ZIP/Postal Code

4790711

Country

Chile

City

Freiburg

State/Province

Baden-Württemberg

ZIP/Postal Code

79106

Country

Germany

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45127

Country

Germany

City

Köln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50931

Country

Germany

City

Bernburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06406

Country

Germany

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39126

Country

Germany

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04207

Country

Germany

City

Hamburg

ZIP/Postal Code

22159

Country

Germany

City

Francavilla Fontana

State/Province

Brindisi

ZIP/Postal Code

72021

Country

Italy

City

Bologna

ZIP/Postal Code

40138

Country

Italy

City

Brescia

ZIP/Postal Code

25123

Country

Italy

City

Milano

ZIP/Postal Code

20121

Country

Italy

City

Modena

ZIP/Postal Code

41124

Country

Italy

City

Perugia

ZIP/Postal Code

06156

Country

Italy

City

Roma

ZIP/Postal Code

00161

Country

Italy

City

Siena

ZIP/Postal Code

53100

Country

Italy

City

Torino

ZIP/Postal Code

10126

Country

Italy

City

Udine

ZIP/Postal Code

33100

Country

Italy

City

Cebu City

Country

Philippines

City

Cebu

Country

Philippines

City

Davao

Country

Philippines

City

Metro Manila

ZIP/Postal Code

1000

Country

Philippines

City

Metro Manila

Country

Philippines

City

Quezon City

Country

Philippines

12. IPD Sharing Statement

Citations:

PubMed Identifier

24713413

Citation

Petraglia F, Parke S, Serrani M, Mellinger U, Romer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int J Gynaecol Obstet. 2014 Jun;125(3):270-4. doi: 10.1016/j.ijgo.2013.11.017. Epub 2014 Mar 11.

Results Reference

derived

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Effect on Primary Dysmenorrhea

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