A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

Study Overview
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Brief Summary
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The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who request long-term, reversible contraception for up to 10 years.

Detailed Description
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This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a levonorgestrel-releasing intrauterine system (LNG20). The goals of the study include provision of information to understand efficacy and safety within the widest range of possible users of the LNG20. Typically, intrauterine contraceptive studies only include women 18-35 years of age for efficacy and safety, and place limits on parity and larger body size. Women outside of these characteristics also desire an effective intrauterine contraceptive. Accordingly, this study will include women who are both nulliparous and parous as well as women less than 18 years of age in the primary efficacy and safety analyses

Official Title
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A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

Conditions
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Contraception

Intervention / Treatment
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* Drug: LNG20
* Drug: Mirena


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women requesting contraception 16-35 years old Cohort 36-45 years old Sexually active Exclusion Criteria: Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy within 24 months of study entry Currently breastfeeding Current persistent, abnormal vaginal bleeding

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LNG20<br>LNG20 levonorgestrel-releasing intrauterine system | Drug: LNG20<br>* levonorgestrel-releasing intrauterine system for contraception<br>|
| Active Comparator: Mirena<br>Levonorgestrel-releasing intrauterine system for contraception | Drug: Mirena<br>* Mirena intrauterine system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy of LNG20 will be assessed by pregnancy rates |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event |  | 10 Years | 
| Levonorgestrel levels |  | 10 Years | 
| Fertility rates one year following removal of the IUS |  | 10 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraception, intrauterine, long-term, reversible