check_circleStudy Completed

Contraception

Bayer Identifier:

91773

ClinicalTrials.gov Identifier:

NCT01638910

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects

Trial purpose

To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years

  • - 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
  • - 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

Trial summary

Enrollment Goal
955
Trial Dates
June 2012 - November 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
National Taiwan University HospitalTaipei, 100, Taiwan
Completed
Chang Gung Memorial Hospital at LinkouTaoyuan, 333, Taiwan
Completed
Wan Fang HospitalTaipei, 116, Taiwan
Completed
Veterans General HospitalTaipei, 11217, Taiwan
Completed
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Completed
Kaohsiung Medical University HospitalKaohsiung, 80756, Taiwan
Completed
Queen Mary HospitalHongkong, Hong Kong
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
King Chulalongkorn Memorial HospitalBangkok, 10330, Thailand
Completed
Obstetrics & Gynecology Hosp. of Fudan Univ.Shanghai, 2100129, China
Completed
Renji Hosp. Shanghai Jiao Tong Univ. School of MedicineShanghai, 200127, China
Completed
International Peace Maternity and Child Health HospitalShanghai, 200030, China
Completed
Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med SchoolShanghai, 200025, China
Completed
Peking Union Medical College HospitalBeijing, 100730, China
Completed
Peking Univ. People's Hosp.Beijing, 100044, China
Completed
2nd affiliated Hospital, Tianjin Medical UniversityTianjin, 300211, China
Completed
Qilu Hosp., Shandong Univ.Jinan, 250012, China
Terminated
Shengjing Hosp. of China Medical Univ.Shenyang, 110004, China
Completed
1st Affiliate Hosp., Dalian Med Univ.Dalian, 116011, China
Completed
People's Hospital of Hebei ProvinceShijiazhuang, 050051, China
Completed
Zhongda Hosp. affiliated of Southeast Univ.Nanjing, 210009, China
Terminated
SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV.Guangzhou, 510120, China
Completed
1st Affiliated Hosp., Guangzhou Univ. TCMGuangzhou,, 510405, China
Completed
Family Plan Research Inst, Tongji Med Colg, Huazhong UniWuhan, 430030, China
Completed
Union Hospital of Tongji Medical College,Huazhong universityWuhan, 430032, China
Completed
The First Affilicated Hospital of 3rd Military Med. Uni.PLAChongqing, 400038, China
Completed
The Third Affiliated Hospital of Third Military Medical Univchongqing, 400042, China
Terminated
1st Hosp., Chongqing Medical Univ.Chongqing, 400016, China
Completed
The Third Xiangya Hospital of Central South UniversityChangsha, 410013, China
Completed
1st Affiliated Hospital of Nanhua UniversityHengyang, 421001, China
Completed
The Second Affiliated Hospitalof Wenzhou Medical CollegeWenzhou, 325027, China
Completed
Maharaj Nakorn Chiang Mai HospitalChiangmai, 50200, Thailand
Completed
Sunshine HospitalSecunderabad, 500003, India
Completed
Bharti Research Institute of Diabetes and EndocrinologyKarnal, 132001, India
Terminated
Gupte Hospital and Centre for Research in ReproductionPune, 411004, India
Terminated
Post Graduate Institute of Medical Education and ResearchChandigarh, India
Completed
Ruby Hall ClinicPune, 411001, India
Terminated
All Inida Institute of Medical SciencesNew Delhi, 110 029, India
Completed
West China 2nd Hosp., of Sichuan Univ.Chengdu, 610041, China

Primary Outcome

  • Number of unintended pregnancies
    date_rangeTime Frame:
    Up to Cycle 13 (1 Cycle = 28 days)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of expected bleeding days
    date_rangeTime Frame:
    Up to Cycle 13 (1 Cycle = 28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Number of unexpected bleeding days
    date_rangeTime Frame:
    Up to Cycle 13 (1 Cycle = 28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Number of expected bleeding episodes
    date_rangeTime Frame:
    Up to Cycle 13 (1 Cycle = 28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Number of unexpected bleeding episodes
    date_rangeTime Frame:
    Up to Cycle 13 (1 Cycle = 28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with Adverse Events as a Measure of Safety and Tolerability
    date_rangeTime Frame:
    Up to Cycle 13 (1 Cycle = 28 days)
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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