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

Information source: Medicines360
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: LNG20 (Drug); Mirena (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Medicines360


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary efficacy of LNG20 will be assessed by pregnancy rates

Secondary outcome:

Adverse event

Levonorgestrel levels

Fertility rates one year following removal of the IUS


Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Female.


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

Locations and Contacts

Chandler, Arizona, United States

Phoenix, Arizona, United States

Palo Alto, California, United States

San Francisco, California, United States

Vista, California, United States

Denver, Colorado, United States

Atlanta, Georgia, United States

Idaho Falls, Idaho, United States

Chicago, Illinois, United States

Des Moines, Iowa, United States

Ann Arbor, Michigan, United States

St. Louis, Missouri, United States

New York City, New York, United States

Chapell Hill, North Carolina, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Magee Women's Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Dallas, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Seattle, Washington, United States

Additional Information

Starting date: November 2009
Last updated: January 21, 2015

Page last updated: August 23, 2015

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