Status:

TERMINATED

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

Lead Sponsor:

Medicines360

Conditions:

Contraception

Eligibility:

FEMALE

16-45 years

Phase:

PHASE3

Brief 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-te...

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 ...

Eligibility Criteria

Inclusion

  • Healthy women requesting contraception
  • 16-35 years old
  • Cohort 36-45 years old
  • Sexually active

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 12 2021

Estimated Enrollment :

1910 Patients enrolled

Trial Details

Trial ID

NCT00995150

Start Date

November 1 2009

End Date

October 12 2021

Last Update

August 14 2024

Active Locations (25)

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Page 1 of 7 (25 locations)

1

Phoenix, Arizona, United States

2

Palo Alto, California, United States

3

San Francisco, California, United States

4

Vista, California, United States