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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995150
• Other study ID #: M360-L102
• Status: Completed
• Phase: Phase 3
• Start date: November 2009
• Est. completion date: October 12, 2021

Study information

• Verified date: August 2022
• Source: Medicines360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1910
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• LNG20
levonorgestrel-releasing intrauterine system for contraception
• Mirena
Mirena intrauterine system

Locations

Country	Name	City	State
United States	Magee Women's Hospital, University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medicines360

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy of LNG20 will be assessed by pregnancy rates		10 years
Secondary	Adverse event		10 Years
Secondary	Levonorgestrel levels		10 Years
Secondary	Fertility rates one year following removal of the IUS		10 Years