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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: April 23, 2013
Last verified: April 2013

October 13, 2009
April 23, 2013
November 2009
December 2017   (final data collection date for primary outcome measure)
The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00995150 on ClinicalTrials.gov Archive Site
  • Adverse event [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Levonorgestrel levels [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Fertility rates one year following removal of the IUS [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
A Phase 3, Randomized, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System (20 Mcg/Day) and Mirena® for Long-Term, Reversible Contraception up to Five Years

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2080
December 2018
December 2017   (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
Female
16 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00995150
M360-L102
Yes
Medicines360
Medicines360
Not Provided
Not Provided
Medicines360
April 2013

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