Trial Condition(s):
GA levonorgestrel intrauterine contraceptive system (LCS) Phase III Study China
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.
- Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS. - Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.) - Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion). - Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
- Known or suspected pregnancy or is lactating. - Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2. Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation. - History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation. - Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1. - Abnormal uterine bleeding of unknown origin. - Any genital infection (until successfully treated). - History of, or current, pelvic inflammatory disease - Congenital or acquired uterine anomaly. - Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS. - History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia. - Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis. - Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study - Clinically significant ovarian cyst(s) - Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.
Locations | Status | ||
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Locations Royal Brisbane and Women's Hospital HERSTON, Australia, 4029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Obstetrics & Gynecology Hosp. of Fudan Univ. Shanghai, China, 200011 | 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 Qilu Hosp., Shandong Univ. Jinan, China | Status Completed | 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 | |
Locations Drum Tower Hospital of Nanjing University Medical School Nanjing, China, 210008 | 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 Cheil general Hospital Seoul, South Korea, 100-380 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Sydney Centre for Reproductive Health Reseach Ashfield, Australia, 2031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations King Edward Memorial Hospital Subiaco, Australia, 6008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Royal Womens Hospital Parkville, Australia, 3052 | 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. First Hosp. Beijing, China, 100034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Peking University Third Hospital Beijing, China, 100191 | 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 1st Hosp., Chongqing Medical Univ. Chongqing, China, 400042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations 2nd Hosp., Chongqing Medical Univ. Chongqing, China, 400010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Tongji Hosp. of Huazhong Univ. of Science & Technology Wuhan, China, 430030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Jiangsu Province Center Nanjing, China | Status Completed | 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 1st Affiliated Hosp., Guangzhou Univ. TCM Guangzhou, China, 510405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Bundang CHA Women's Hospital Sungnam-si , South Korea, 463-712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Severance Hospital, Yonsei University College of Medicine Seoul, South Korea, 120-752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Multi-center, open label, single arm study to assess efficacy, safety, bleeding pattern and pharmacokinetics of the ultra low dose levonorgestrel intrauterine contraceptive system (LCS) for a maximum of 3 years in women 18 to 40 years of age
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1