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

Medicines360

Status and phase: Terminated; Phase 3

Conditions: Contraception

Treatments: Drug: LNG20; Drug: Mirena

Study type: Interventional

Funder types: Other

Identifiers

NCT00995150

M360-L102

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,910 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,910 participants in 3 patient groups

LNG20 (16-35 Year Olds)

Experimental group

Description:

LNG20 levonorgestrel-releasing intrauterine system in subjects 16-35 years of age

Treatment:

Drug: LNG20

Mirena

Active Comparator group

Description:

Levonorgestrel-releasing intrauterine system for contraception

Treatment:

Drug: Mirena

LNG20 (36-45 Year Olds)

Experimental group

Description:

LNG20 levonorgestrel-releasing intrauterine system in subjects 36-45 years of age

Treatment:

Drug: LNG20