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Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

Primary Purpose

Metrorrhagia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EV/DNG (Qlaira, Natazia, BAY86-5027)
placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metrorrhagia focused on measuring Heavy Menstrual Bleeding, Efficacy, Safety, Oral contraceptive, Estradiol valerate, Dienogest

Eligibility Criteria

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

Inclusion Criteria:

  • Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception
  • Willingness to use barrier contraception (e.g., condoms) from screening to study completion
  • Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion

Exclusion Criteria:

  • Current diagnosis of organic uterine bleeding
  • History of endometrial ablation, or dilatation and curettage within 2 months of Visit 1.
  • Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound [TVU]).
  • Clinically significant abnormal results of breast examination (breast palpation).
  • Positive pregnancy test at Visit 1
  • Less than three months since delivery, abortion, or lactation before to start Visit 1
  • Other contraceptive methods
  • Any disease or condition that may worsen under hormonal treatment
  • Smokers over the age of 35
  • Body mass index >32

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days

Secondary Outcome Measures

Proportion of subjects with successful treatment
Successful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value </=50% of MBL compared to 90 day run-in period
Percent change of MBL at baseline and 90 day period during treatment phase
Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)
Proportion of subjects with improvement in the investigator's global assessment scale on Day 84
Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Proportion of subjects with improvement in the investigator's global assessment scale on Day 196
Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Proportion of subjects with improvement in the subject's global assessment scale on Day 84
Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Proportion of subjects with improvement in the subject's global assessment scale on Day 196
Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Number of participants with adverse events as a measure of safety and tolerability

Full Information

First Posted
June 20, 2012
Last Updated
July 8, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01638923
Brief Title
Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding
Official Title
A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (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
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metrorrhagia
Keywords
Heavy Menstrual Bleeding, Efficacy, Safety, Oral contraceptive, Estradiol valerate, Dienogest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EV/DNG (Qlaira, Natazia, BAY86-5027)
Intervention Description
2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Matching placebo to be taken orally daily for 7 cycles of 28 days each.
Primary Outcome Measure Information:
Title
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
Time Frame
90 day baseline period and 90 days during treatment period
Secondary Outcome Measure Information:
Title
Proportion of subjects with successful treatment
Description
Successful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value </=50% of MBL compared to 90 day run-in period
Time Frame
90 days during treatment phase
Title
Percent change of MBL at baseline and 90 day period during treatment phase
Time Frame
Baseline and 90 days during treatment phase
Title
Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)
Time Frame
Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7
Title
Proportion of subjects with improvement in the investigator's global assessment scale on Day 84
Description
Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Time Frame
Treatment day 84
Title
Proportion of subjects with improvement in the investigator's global assessment scale on Day 196
Description
Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Time Frame
Treatment day 196
Title
Proportion of subjects with improvement in the subject's global assessment scale on Day 84
Description
Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Time Frame
Treatment day 84
Title
Proportion of subjects with improvement in the subject's global assessment scale on Day 196
Description
Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Time Frame
Treatment day 196
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception Willingness to use barrier contraception (e.g., condoms) from screening to study completion Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion Exclusion Criteria: Current diagnosis of organic uterine bleeding History of endometrial ablation, or dilatation and curettage within 2 months of Visit 1. Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound [TVU]). Clinically significant abnormal results of breast examination (breast palpation). Positive pregnancy test at Visit 1 Less than three months since delivery, abortion, or lactation before to start Visit 1 Other contraceptive methods Any disease or condition that may worsen under hormonal treatment Smokers over the age of 35 Body mass index >32
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430032
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
City
Beijing
ZIP/Postal Code
100026
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Changchun
Country
China
City
Chongqing
ZIP/Postal Code
400010
Country
China
City
Qingdao
ZIP/Postal Code
266071
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
ZIP/Postal Code
2100129
Country
China
City
Tianjin
ZIP/Postal Code
300193
Country
China
City
Tianjin
ZIP/Postal Code
300211
Country
China
City
Manila
Country
Philippines
City
Quezon City
Country
Philippines
City
Irkutsk
ZIP/Postal Code
664003
Country
Russian Federation
City
Ivanovo
ZIP/Postal Code
153045
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350012
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117415
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

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