GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China
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
3 other identifiers
interventional
918
3 countries
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2009
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 21, 2014
August 1, 2014
4.2 years
April 16, 2009
August 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
3 years
Secondary Outcomes (4)
LCS expulsion rate
3 years
Discontinuation rates
3 years
Adverse events
3 years
Laboratory tests
3 years
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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 regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (25)
Unknown Facility
Ashfield, New South Wales, 2031, Australia
Unknown Facility
Herston, Queensland, 4029, Australia
Unknown Facility
Parkville, Victoria, 3052, Australia
Unknown Facility
Subiaco, Western Australia, 6008, Australia
Unknown Facility
Guangzhou, Guangdong, 510405, China
Unknown Facility
Wuhan, Hubei, 430030, China
Unknown Facility
Nanjing, Jiangsu, 210008, China
Unknown Facility
Nanjing, Jiangsu, 210009, China
Unknown Facility
Nanjing, Jiangsu, China
Unknown Facility
Dalian, Liaoning, 116011, China
Unknown Facility
Jinan, Shandong, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100191, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Chongqing, 400010, China
Unknown Facility
Chongqing, 400042, China
Unknown Facility
Shanghai, 200011, China
Unknown Facility
Shanghai, 200025, China
Unknown Facility
Shanghai, 200127, China
Unknown Facility
Sungnam-si, Gyeonggido, 463-712, South Korea
Unknown Facility
Seoul, Korea, 100-380, South Korea
Unknown Facility
Seoul, 110-744, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 20, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 21, 2014
Record last verified: 2014-08