check_circleStudy Completed

Contraception

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

Female

Age

18 - 40 Years
  • - 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.

Trial summary

Enrollment Goal
918
Trial Dates
April 2009 - June 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Royal Brisbane and Women's HospitalHERSTON, 4029, Australia
Completed
Obstetrics & Gynecology Hosp. of Fudan Univ.Shanghai, 200011, China
Completed
Renji Hosp. Shanghai Jiao Tong Univ. School of MedicineShanghai, 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 SchoolNanjing, 210008, China
Completed
Zhongda Hosp. affiliated of Southeast Univ.Nanjing, 210009, China
Completed
Cheil general HospitalSeoul, 100-380, Korea, Republic Of
Completed
Sydney Centre for Reproductive Health ReseachAshfield, 2031, Australia
Completed
King Edward Memorial HospitalSubiaco, 6008, Australia
Completed
Royal Womens HospitalParkville, 3052, Australia
Completed
Peking Union Medical College HospitalBeijing, 100730, China
Completed
Peking Univ. First Hosp.Beijing, 100034, China
Completed
Peking University Third HospitalBeijing, 100191, China
Completed
Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med SchoolShanghai, 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 & TechnologyWuhan, 430030, China
Completed
Jiangsu Province CenterNanjing, China
Completed
1st Affiliate Hosp., Dalian Med Univ.Dalian, 116011, China
Completed
1st Affiliated Hosp., Guangzhou Univ. TCMGuangzhou, 510405, China
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Bundang CHA Women's HospitalSungnam-si, 463-712, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, 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 years
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • LCS expulsion rate
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    no
  • Discontinuation rates
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    no
  • Adverse events
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    yes
  • Laboratory tests
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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