Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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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: January 21, 2015
Last verified: January 2015
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.


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 ]
Estimated Enrollment: 2080
Study Start Date: November 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (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

  Eligibility
Ages Eligible for Study:   16 Years to 45 Years
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
  More Information

No publications provided

Responsible Party: Medicines360
ClinicalTrials.gov Identifier: NCT00995150     History of Changes
Other Study ID Numbers: M360-L102
Study First Received: October 13, 2009
Last Updated: January 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medicines360:
contraception
intrauterine
long-term
reversible

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

ClinicalTrials.gov processed this record on March 03, 2015