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

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ClinicalTrials.gov Identifier: NCT00995150
Recruitment Status : Active, not recruiting
First Posted : October 15, 2009
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Medicines360

Study Description
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Brief Summary:
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 10 years.

Condition or disease Intervention/treatment Phase
Contraception Drug: LNG20 Drug: Mirena Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1910 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Adverse event [ Time Frame: 10 Years ]
  2. Levonorgestrel levels [ Time Frame: 10 Years ]
  3. Fertility rates one year following removal of the IUS [ Time Frame: 10 Years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995150


  Show 25 Study Locations
Sponsors and Collaborators
Medicines360
Investigators
Study Director: Andrea Olariu, MD, PhD Chief Medical Officer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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