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

August 4, 2022 updated by: Medicines360

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment (Actual)

1910

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Palo Alto, California, United States
      • San Francisco, California, United States
      • Vista, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital, University of Pittsburgh
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LNG20
LNG20 levonorgestrel-releasing intrauterine system
Drug: LNG20
levonorgestrel-releasing intrauterine system for contraception
Active Comparator: Mirena
Levonorgestrel-releasing intrauterine system for contraception
Drug: Mirena
Mirena intrauterine system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy of LNG20 will be assessed by pregnancy rates
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event
Time Frame: 10 Years
10 Years
Levonorgestrel levels
Time Frame: 10 Years
10 Years
Fertility rates one year following removal of the IUS
Time Frame: 10 Years
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicines360

Investigators

  • Study Director: Andrea Olariu, MD, PhD, COO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

October 12, 2021

Study Completion (Actual)

October 12, 2021

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M360-L102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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