GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel IUS (LCS, BAY86-5028)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levonorgestrel IUS (LCS, BAY86-5028)<br>* In Vitro release rate: 12µg LNG/24h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LCS expulsion rate |  | 3 years | 
| Discontinuation rates |  | 3 years | 
| Adverse events |  | 3 years | 
| Laboratory tests |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Intrauterine contraception system