Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding
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
2 other identifiers
interventional
339
6 countries
41
Brief Summary
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2012
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 10, 2015
July 1, 2015
3 years
June 20, 2012
July 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
90 day baseline period and 90 days during treatment period
Secondary Outcomes (8)
Proportion of subjects with successful treatment
90 days during treatment phase
Percent change of MBL at baseline and 90 day period during treatment phase
Baseline and 90 days during treatment phase
Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)
Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7
Proportion of subjects with improvement in the investigator's global assessment scale on Day 84
Treatment day 84
Proportion of subjects with improvement in the investigator's global assessment scale on Day 196
Treatment day 196
- +3 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (41)
Unknown Facility
Guangzhou, Guangdong, 510120, China
Unknown Facility
Nanning, Guangxi, 530021, China
Unknown Facility
Shijiazhuang, Hebei, 050051, China
Unknown Facility
Wuhan, Hubei, 430030, China
Unknown Facility
Wuhan, Hubei, 430032, China
Unknown Facility
Changsha, Hunan, 410013, China
Unknown Facility
Hengyang, Hunan, 421001, China
Unknown Facility
Dalian, Liaoning, 116011, China
Unknown Facility
Shenyang, Liaoning, 110004, China
Unknown Facility
Xi'an, Shaanxi, 710032, China
Unknown Facility
Jinan, Shandong, 250012, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Chengdu, Sichuan, 610072, China
Unknown Facility
Beijing, 100026, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Changchun, China
Unknown Facility
Chongqing, 400010, China
Unknown Facility
Qingdao, 266071, China
Unknown Facility
Shanghai, 200030, China
Unknown Facility
Shanghai, 2100129, China
Unknown Facility
Tianjin, 300193, China
Unknown Facility
Tianjin, 300211, China
Unknown Facility
Manila, Philippines
Unknown Facility
Quezon City, Philippines
Unknown Facility
Irkutsk, 664003, Russia
Unknown Facility
Ivanovo, 153045, Russia
Unknown Facility
Krasnodar, 350012, Russia
Unknown Facility
Moscow, 117049, Russia
Unknown Facility
Moscow, 117415, Russia
Unknown Facility
Saint Petersburg, 194354, Russia
Unknown Facility
Saint Petersburg, 199034, Russia
Unknown Facility
Singapore, 169608, Singapore
Unknown Facility
Singapore, 229899, Singapore
Unknown Facility
Taichung, 40705, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taipei, 11217, Taiwan
Unknown Facility
Bangkok, 10330, Thailand
Unknown Facility
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2012
First Posted
July 12, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 10, 2015
Record last verified: 2015-07