NCT00995150

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,910 (actual)
• Sponsor: Medicines360 · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	LNG20	levonorgestrel-releasing intrauterine system for contraception
DRUG	Mirena	Mirena intrauterine system

Timeline

• Start date: 2009-11-01
• Primary completion: 2021-10-12
• Completion: 2021-10-12
• First posted: 2009-10-15
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study