check_circleStudy Completed
Contraception
Bayer Identifier:
91775
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
GA levonorgestrel intrauterine contraceptive system (LCS) Phase III Study China
Trial purpose
The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.
Key Participants Requirements
Sex
FemaleAge
18 - 40 YearsTrial summary
Enrollment Goal
918Trial Dates
April 2009 - June 2013Phase
Phase 3Could I Receive a placebo
NoProducts
Skyla (Levonorgestrel, BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Royal Brisbane and Women's Hospital | HERSTON, 4029, Australia |
Completed | Obstetrics & Gynecology Hosp. of Fudan Univ. | Shanghai, 200011, China |
Completed | Renji Hosp. Shanghai Jiao Tong Univ. School of Medicine | Shanghai, 200127, China |
Completed | Qilu Hosp., Shandong Univ. | Jinan, China |
Completed | West China 2nd Hosp., of Sichuan Univ. | Chengdu, 610041, China |
Completed | Drum Tower Hospital of Nanjing University Medical School | Nanjing, 210008, China |
Completed | Zhongda Hosp. affiliated of Southeast Univ. | Nanjing, 210009, China |
Completed | Cheil general Hospital | Seoul, 100-380, Korea, Republic Of |
Completed | Sydney Centre for Reproductive Health Reseach | Ashfield, 2031, Australia |
Completed | King Edward Memorial Hospital | Subiaco, 6008, Australia |
Completed | Royal Womens Hospital | Parkville, 3052, Australia |
Completed | Peking Union Medical College Hospital | Beijing, 100730, China |
Completed | Peking Univ. First Hosp. | Beijing, 100034, China |
Completed | Peking University Third Hospital | Beijing, 100191, China |
Completed | Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School | Shanghai, 200025, China |
Completed | 1st Hosp., Chongqing Medical Univ. | Chongqing, 400042, China |
Completed | 2nd Hosp., Chongqing Medical Univ. | Chongqing, 400010, China |
Completed | Tongji Hosp. of Huazhong Univ. of Science & Technology | Wuhan, 430030, China |
Completed | Jiangsu Province Center | Nanjing, China |
Completed | 1st Affiliate Hosp., Dalian Med Univ. | Dalian, 116011, China |
Completed | 1st Affiliated Hosp., Guangzhou Univ. TCM | Guangzhou, 510405, China |
Completed | Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Bundang CHA Women's Hospital | Sungnam-si, 463-712, Korea, Republic Of |
Completed | Seoul National University Hospital | Seoul, 110-744, Korea, Republic Of |
Completed | Severance Hospital, Yonsei University College of Medicine | Seoul, 120-752, Korea, Republic Of |
Primary Outcome
- Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.date_rangeTime Frame:3 yearsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- LCS expulsion ratedate_rangeTime Frame:3 yearsenhanced_encryptionnoSafety Issue:
- Discontinuation ratesdate_rangeTime Frame:3 yearsenhanced_encryptionnoSafety Issue:
- Adverse eventsdate_rangeTime Frame:3 yearsenhanced_encryptionyesSafety Issue:
- Laboratory testsdate_rangeTime Frame:3 yearsenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1