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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00995150
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Medicines360

Study Description
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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-term, reversible contraception for up to 10 years.

Condition or disease Intervention/treatment Phase
Contraception Drug: LNG20 Drug: Mirena Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1910 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Actual Study Start Date : November 2009
Actual Primary Completion Date : October 12, 2021
Actual Study Completion Date : October 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Adverse event [ Time Frame: 10 Years ]
  2. Levonorgestrel levels [ Time Frame: 10 Years ]
  3. Fertility rates one year following removal of the IUS [ Time Frame: 10 Years ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995150


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, California
Palo Alto, California, United States
San Francisco, California, United States
Vista, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Idaho
Idaho Falls, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Women's Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Medicines360
Investigators
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Study Director: Andrea Olariu, MD, PhD COO
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medicines360
ClinicalTrials.gov Identifier: NCT00995150    
Other Study ID Numbers: M360-L102
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medicines360:
contraception
intrauterine
long-term
reversible
Additional relevant MeSH terms:
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Levonorgestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral