Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects
A Multi-center, Open, Uncontrolled Phase 3 Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T00658ID Containing Estradiol Valerate and Dienogest in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
1 other identifier
interventional
955
5 countries
39
Brief Summary
To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2012
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 17, 2014
December 1, 2014
2.4 years
June 20, 2012
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of unintended pregnancies
Up to Cycle 13 (1 Cycle = 28 days)
Secondary Outcomes (5)
Number of expected bleeding days
Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding days
Up to Cycle 13 (1 Cycle = 28 days)
Number of expected bleeding episodes
Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding episodes
Up to Cycle 13 (1 Cycle = 28 days)
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Up to Cycle 13 (1 Cycle = 28 days)
Study Arms (1)
EV/DNG (Qlaira, BAY86-5027)
EXPERIMENTALInterventions
Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
Eligibility Criteria
You may qualify if:
- Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception
- Smokers may not exceed 35 years of age
You may not qualify if:
- Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment)
- Body mass index (BMI) \> 32 kg/m2
- Any disease or condition that may worsen under hormonal treatment
- Undiagnosed abnormal genital bleeding
- Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment
- Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (39)
Unknown Facility
Guangzhou, Guangdong, 510120, China
Unknown Facility
Guangzhou, Guangdong, 510405, 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
Nanjing, Jiangsu, 210009, China
Unknown Facility
Dalian, Liaoning, 116011, China
Unknown Facility
Shenyang, Liaoning, 110004, China
Unknown Facility
Jinan, Shandong, 250012, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Wenzhou, Zhejiang, 325027, China
Unknown Facility
Beijing, 100044, China
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Beijing, 100730, China
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Chongqing, 400016, China
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Chongqing, 400038, China
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Chongqing, 400042, China
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Shanghai, 200025, China
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Shanghai, 200030, China
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Shanghai, 200127, China
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Shanghai, 2100129, China
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Tianjin, 300211, China
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Hong Kong, Hong Kong
Unknown Facility
Pune, Maharashtra, 411001, India
Unknown Facility
Chandigarh, India
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Karnāl, 132001, India
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New Delhi, 110 029, India
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Pune, 411004, India
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Secunderabad, 500003, India
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Taipei, Taipei, 116, Taiwan
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Kaohsiung City, 80756, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11217, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Unknown Facility
Bangkok, Thailand, 10330, Thailand
Unknown Facility
Bangkok, 10700, Thailand
Unknown Facility
Chiang Mai, 50200, Thailand
Related Publications (1)
Yu Q, Huang Z, Ren M, Chang Q, Zhang Z, Parke S. Contraceptive efficacy and safety of estradiol valerate/dienogest in a healthy female population: a multicenter, open-label, uncontrolled Phase III study. Int J Womens Health. 2018 Jun 7;10:257-266. doi: 10.2147/IJWH.S157056. eCollection 2018.
PMID: 29922096DERIVED
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- 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
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 17, 2014
Record last verified: 2014-12