Trial Condition(s):
Contraception
Efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects
Bayer Identifier:
91773
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 333 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wan Fang Hospital Taipei, Taiwan, China, 116 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaohsiung Medical University Hospital Kaohsiung , Taiwan, China, 80756 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital Hongkong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations King Chulalongkorn Memorial Hospital Bangkok, Thailand, 10330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Obstetrics & Gynecology Hosp. of Fudan Univ. Shanghai, China, 2100129 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Renji Hosp. Shanghai Jiao Tong Univ. School of Medicine Shanghai, China, 200127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations International Peace Maternity and Child Health Hospital Shanghai, China, 200030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School Shanghai, China, 200025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking Union Medical College Hospital Beijing, China, 100730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking Univ. People's Hosp. Beijing, China, 100044 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 2nd affiliated Hospital, Tianjin Medical University Tianjin, China, 300211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Qilu Hosp., Shandong Univ. Jinan, China, 250012 | Status Completed | Contact Us: E-mail: [email protected].com Phone: Not Available |
Locations Shengjing Hosp. of China Medical Univ. Shenyang, China, 110004 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliate Hosp., Dalian Med Univ. Dalian, China, 116011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations People's Hospital of Hebei Province Shijiazhuang, China, 050051 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhongda Hosp. affiliated of Southeast Univ. Nanjing, China, 210009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV. Guangzhou, China, 510120 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hosp., Guangzhou Univ. TCM Guangzhou, , China, 510405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Family Plan Research Inst, Tongji Med Colg, Huazhong Uni Wuhan, China, 430030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Union Hospital of Tongji Medical College,Huazhong university Wuhan, China, 430032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The First Affilicated Hospital of 3rd Military Med. Uni.PLA Chongqing, China, 400038 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Third Affiliated Hospital of Third Military Medical Univ chongqing, China, 400042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Hosp., Chongqing Medical Univ. Chongqing, China, 400016 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Third Xiangya Hospital of Central South University Changsha, China, 410013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hospital of Nanhua University Hengyang, China, 421001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Second Affiliated Hospitalof Wenzhou Medical College Wenzhou, China, 325027 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maharaj Nakorn Chiang Mai Hospital Chiangmai, Thailand, 50200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunshine Hospital Secunderabad, India, 500003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bharti Research Institute of Diabetes and Endocrinology Karnal, India, 132001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gupte Hospital and Centre for Research in Reproduction Pune, India, 411004 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Post Graduate Institute of Medical Education and Research Chandigarh, India | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ruby Hall Clinic Pune, India, 411001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations All Inida Institute of Medical Sciences New Delhi, India, 110 029 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China 2nd Hosp., of Sichuan Univ. Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of unintended pregnanciesTimeframe: Up to Cycle 13 (1 Cycle = 28 days)
Secondary Outcome
- Number of expected bleeding daysTimeframe: Up to Cycle 13 (1 Cycle = 28 days)
- Number of unexpected bleeding daysTimeframe: Up to Cycle 13 (1 Cycle = 28 days)
- Number of expected bleeding episodesTimeframe: Up to Cycle 13 (1 Cycle = 28 days)
- Number of unexpected bleeding episodesTimeframe: Up to Cycle 13 (1 Cycle = 28 days)
- Number of participants with Adverse Events as a Measure of Safety and TolerabilityTimeframe: Up to Cycle 13 (1 Cycle = 28 days)
Additional Information
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