check_circleStudy Completed
Contraception
Bayer Identifier:
91773
ClinicalTrials.gov Identifier:
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
FemaleAge
18 - 50 YearsTrial summary
Enrollment Goal
955Trial Dates
June 2012 - November 2014Phase
Phase 3Could I Receive a placebo
NoProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | National Taiwan University Hospital | Taipei, 100, Taiwan |
Completed | Chang Gung Memorial Hospital at Linkou | Taoyuan, 333, Taiwan |
Completed | Wan Fang Hospital | Taipei, 116, Taiwan |
Completed | Veterans General Hospital | Taipei, 11217, Taiwan |
Completed | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Completed | Kaohsiung Medical University Hospital | Kaohsiung, 80756, Taiwan |
Completed | Queen Mary Hospital | Hongkong, Hong Kong |
Completed | Siriraj Hospital, Mahidol | Bangkok, 10700, Thailand |
Completed | King Chulalongkorn Memorial Hospital | Bangkok, 10330, Thailand |
Completed | Obstetrics & Gynecology Hosp. of Fudan Univ. | Shanghai, 2100129, China |
Completed | Renji Hosp. Shanghai Jiao Tong Univ. School of Medicine | Shanghai, 200127, China |
Completed | International Peace Maternity and Child Health Hospital | Shanghai, 200030, China |
Completed | Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School | Shanghai, 200025, China |
Completed | Peking Union Medical College Hospital | Beijing, 100730, China |
Completed | Peking Univ. People's Hosp. | Beijing, 100044, China |
Completed | 2nd affiliated Hospital, Tianjin Medical University | Tianjin, 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 Province | Shijiazhuang, 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. TCM | Guangzhou,, 510405, China |
Completed | Family Plan Research Inst, Tongji Med Colg, Huazhong Uni | Wuhan, 430030, China |
Completed | Union Hospital of Tongji Medical College,Huazhong university | Wuhan, 430032, China |
Completed | The First Affilicated Hospital of 3rd Military Med. Uni.PLA | Chongqing, 400038, China |
Completed | The Third Affiliated Hospital of Third Military Medical Univ | chongqing, 400042, China |
Terminated | 1st Hosp., Chongqing Medical Univ. | Chongqing, 400016, China |
Completed | The Third Xiangya Hospital of Central South University | Changsha, 410013, China |
Completed | 1st Affiliated Hospital of Nanhua University | Hengyang, 421001, China |
Completed | The Second Affiliated Hospitalof Wenzhou Medical College | Wenzhou, 325027, China |
Completed | Maharaj Nakorn Chiang Mai Hospital | Chiangmai, 50200, Thailand |
Completed | Sunshine Hospital | Secunderabad, 500003, India |
Completed | Bharti Research Institute of Diabetes and Endocrinology | Karnal, 132001, India |
Terminated | Gupte Hospital and Centre for Research in Reproduction | Pune, 411004, India |
Terminated | Post Graduate Institute of Medical Education and Research | Chandigarh, India |
Completed | Ruby Hall Clinic | Pune, 411001, India |
Terminated | All Inida Institute of Medical Sciences | New Delhi, 110 029, India |
Completed | West China 2nd Hosp., of Sichuan Univ. | Chengdu, 610041, China |
Primary Outcome
- Number of unintended pregnanciesdate_rangeTime Frame:Up to Cycle 13 (1 Cycle = 28 days)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of expected bleeding daysdate_rangeTime Frame:Up to Cycle 13 (1 Cycle = 28 days)enhanced_encryptionNoSafety Issue:
- Number of unexpected bleeding daysdate_rangeTime Frame:Up to Cycle 13 (1 Cycle = 28 days)enhanced_encryptionNoSafety Issue:
- Number of expected bleeding episodesdate_rangeTime Frame:Up to Cycle 13 (1 Cycle = 28 days)enhanced_encryptionNoSafety Issue:
- Number of unexpected bleeding episodesdate_rangeTime Frame:Up to Cycle 13 (1 Cycle = 28 days)enhanced_encryptionNoSafety Issue:
- Number of participants with Adverse Events as a Measure of Safety and Tolerabilitydate_rangeTime Frame:Up to Cycle 13 (1 Cycle = 28 days)enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1