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SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SH T04740B
SH T00186DF
SH T04740F
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Dysmenorrhea, Dysmenorrheal score, Drospirenone, DRSP, Ethinylestradiol

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 20 years or older at obtaining informed consent
  • Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment
  • Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment

Exclusion Criteria:

  • Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol)
  • Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
  • Patients with undiagnosed abnormal vaginal bleeding
  • Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases
  • Patients aged 35 years or older who smoke at least 15 cigarettes per day
  • Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation)
  • Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis
  • Patients who are regularly taking nutritional products that contain St. John's Wort
  • Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening
  • Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

DRSP 1 mg/EE 20 μg

DRSP 2 mg/EE 20 μg

DRSP 3 mg/EE 20 μg

Placebo

Arm Description

1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle

1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle

1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle

1 tablet per day placebo for 28 days in each 28-day cycle

Outcomes

Primary Outcome Measures

Change From Baseline in Total Dysmenorrheal Score at Final Evaluation
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)

Secondary Outcome Measures

Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Number of Participants With Severity of Headache During Menstruation at Cycle 4
Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Change From Baseline in Endometrial Thickness After 4-cycle Treatment
Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.
Number of Bleeding / Spotting Episodes
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.
Number of Bleeding / Spotting Days
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.
Participants With Withdrawal Bleeding
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Participants With Intracyclic Bleeding
Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
Participants With Non-heavy Intracyclic Bleeding
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Participants With Non-heavy Withdrawal Bleeding
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment
CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.
Change From Baseline in Serum Estradiol Level After 4-cycle Treatment
Estradiol is a predominant sex hormone that presents in female.
Change From Baseline in Serum Progesterone Level at Cycle 4
Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.

Full Information

First Posted
August 3, 2007
Last Updated
November 30, 2016
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00511797
Brief Title
SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
Dysmenorrhea, Dysmenorrheal score, Drospirenone, DRSP, Ethinylestradiol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRSP 1 mg/EE 20 μg
Arm Type
Experimental
Arm Description
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
Arm Title
DRSP 2 mg/EE 20 μg
Arm Type
Experimental
Arm Description
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
Arm Title
DRSP 3 mg/EE 20 μg
Arm Type
Experimental
Arm Description
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet per day placebo for 28 days in each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
SH T04740B
Intervention Description
Drospirenone 1mg/EE 20µg (ß-CDC)
Intervention Type
Drug
Intervention Name(s)
SH T00186DF
Intervention Description
Drospirenone 3 mg/EE 20µg (ß-CDC)
Intervention Type
Drug
Intervention Name(s)
SH T04740F
Intervention Description
Drospirenone 2 mg/EE 20µg (ß-CDC)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation
Description
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Time Frame
Baseline and up to 4 Cycles (28 days per cycle)
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Description
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.
Time Frame
Baseline and up to 4 Cycles (28 days per cycle)
Title
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
Description
Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame
Cycle 4 (28 days per cycle)
Title
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
Description
Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame
Cycle 4 (28 days per cycle)
Title
Number of Participants With Severity of Headache During Menstruation at Cycle 4
Description
Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame
Cycle 4 (28 days per cycle)
Title
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
Description
Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame
Cycle 4 (28 days per cycle)
Title
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
Description
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame
Cycle 4 (28 days per cycle)
Title
Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4
Description
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame
From baseline up to Cycle 4 (28 days per cycle)
Title
Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4
Description
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame
Cycle 4 (28 days per cycle)
Title
Change From Baseline in Endometrial Thickness After 4-cycle Treatment
Description
Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.
Time Frame
From baseline to Cycle 4 (28 days per cycle)
Title
Number of Bleeding / Spotting Episodes
Description
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.
Time Frame
For the first 90 days
Title
Number of Bleeding / Spotting Days
Description
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.
Time Frame
For the first 90 days
Title
Participants With Withdrawal Bleeding
Description
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Time Frame
At Cycle 4 (28 days per cycle)
Title
Participants With Intracyclic Bleeding
Description
Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
Time Frame
At Cycle 4 (28 days per cycle)
Title
Participants With Non-heavy Intracyclic Bleeding
Description
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Time Frame
At Cycle 4 (28 days per cycle)
Title
Participants With Non-heavy Withdrawal Bleeding
Description
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Time Frame
At Cycle 4 (28 dyas per cycle)
Title
Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment
Description
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Time Frame
From baseline to Cycle 4 (28 days per cycle)
Title
Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment
Description
CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.
Time Frame
From baseline to Cycle 4 (28 days per cycle)
Title
Change From Baseline in Serum Estradiol Level After 4-cycle Treatment
Description
Estradiol is a predominant sex hormone that presents in female.
Time Frame
From baseline to Cycle 4 (28 days per cycle)
Title
Change From Baseline in Serum Progesterone Level at Cycle 4
Description
Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.
Time Frame
From baseline to Cycle 4 (28 days per cycle)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20 years or older at obtaining informed consent Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment Exclusion Criteria: Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol) Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.) Patients with undiagnosed abnormal vaginal bleeding Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases Patients aged 35 years or older who smoke at least 15 cigarettes per day Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation) Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis Patients who are regularly taking nutritional products that contain St. John's Wort Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0024
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0021
Country
Japan
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8204
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-0861
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-0933
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0061
Country
Japan
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
156-0042
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-0066
Country
Japan
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
City
Kyoto
ZIP/Postal Code
612-0064
Country
Japan
City
Osaka
ZIP/Postal Code
530-0013
Country
Japan

12. IPD Sharing Statement

Citations:
Citation
Momoeda M, et al. Treatment of Functional and Organic Dysmenorrhea - Investigation of the Efficacy and Safety of Drospirenone/Ethinylestradiol Combination Tablet (YAZ). Sanka to Fujinka (Obstetrics and Gynecology), 2010: 77 (8) 977-88 (in Japanese)
Results Reference
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SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

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