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

  • Interventional
  • Not Recruiting
  • NCT00995150
Eligibility Details Visit Clinicaltrials.gov

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

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.

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

Gender
Female

Age Group
16 Years to 45 Years

Accepting Healthy 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

At a Glance

National Government IDNCT00995150

IRB#10-067-B

Lead SponsorMedicines360

Lead PhysicianMelissa Gilliam

Collaborator(s)N/A

EligibilityFemale
16 Years to 45 Years
Not Recruiting