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
  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, 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

Resource links provided by NLM:


Further study details as provided by Medicines360:

Primary Outcome Measures:
  • The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
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: April 23, 2013
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
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on April 23, 2014