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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:
ClinicalTrials.gov Identifier:
NCT00995150
First Posted: October 15, 2009
Last Update Posted: December 15, 2016
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.
Information provided by (Responsible Party):
Medicines360
October 13, 2009
October 15, 2009
December 15, 2016
November 2009
December 2020   (Final data collection date for primary outcome measure)
The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 8 years ]
The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00995150 on ClinicalTrials.gov Archive Site
  • Adverse event [ Time Frame: 8 Years ]
  • Levonorgestrel levels [ Time Frame: 8 Years ]
  • Fertility rates one year following removal of the IUS [ Time Frame: 8 Years ]
  • Adverse event [ Time Frame: 5 Years ]
  • Levonorgestrel levels [ Time Frame: 5 Years ]
  • Fertility rates one year following removal of the IUS [ Time Frame: 5 Years ]
Not Provided
Not Provided
 
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
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 8 years.
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Contraception
  • Drug: LNG20
    levonorgestrel-releasing intrauterine system for contraception
  • Drug: Mirena
    Mirena intrauterine system
  • Experimental: LNG20
    LNG20 levonorgestrel-releasing intrauterine system
    Intervention: Drug: LNG20
  • Active Comparator: Mirena
    Levonorgestrel-releasing intrauterine system for contraception
    Intervention: Drug: Mirena
Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD; ACCESS IUS Investigators. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015 Jul;92(1):10-6. doi: 10.1016/j.contraception.2015.04.006. Epub 2015 Apr 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1910
December 2021
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
16 Years to 45 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00995150
M360-L102
Yes
Not Provided
Plan to Share IPD: Yes
Medicines360
Medicines360
Not Provided
Study Director: Andrea Olariu, MD, PhD Chief Medical Officer
Medicines360
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP