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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medicines360
ClinicalTrials.gov Identifier:
NCT00995150
First received: October 13, 2009
Last updated: September 14, 2016
Last verified: September 2016
History of Changes
  Purpose
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 7 years.

Condition Intervention Phase
Contraception
 Drug: LNG20
Drug: Mirena
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Medicines360:

Primary Outcome Measures:
  • The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event [ Time Frame: 7 Years ] [ Designated as safety issue: Yes ]
  • Levonorgestrel levels [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
  • Fertility rates one year following removal of the IUS [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
Enrollment: 1910
Study Start Date: November 2009
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility
Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995150

  Show 27 Study Locations
Sponsors and Collaborators
Medicines360
Investigators
Study Director: Andrea Olariu, MD, PhD Chief Medical Officer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medicines360
ClinicalTrials.gov Identifier: NCT00995150     History of Changes
Other Study ID Numbers: M360-L102 
Study First Received: October 13, 2009
Last Updated: September 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medicines360:
contraception
intrauterine
long-term
reversible

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on September 27, 2016