A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
This study is ongoing, but not recruiting participants.
Sponsor:
Medicines360
Information provided by (Responsible Party):
Medicines360
ClinicalTrials.gov Identifier:
NCT00995150
First received: October 13, 2009
Last updated: April 23, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Birth Control
Drug Information available for:
Levonorgestrel
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: 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
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Hide Study LocationsLocations
| United States, Arizona | |
| Chandler, Arizona, United States | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Palo Alto, California, United States | |
| San Francisco, California, United States | |
| Vista, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| United States, Idaho | |
| Idaho Falls, Idaho, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Iowa | |
| Des Moines, Iowa, United States | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| New York City, New York, United States | |
| United States, North Carolina | |
| Chapell Hill, North Carolina, United States | |
| United States, Ohio | |
| Akron, Ohio, United States | |
| Cincinnati, Ohio, United States | |
| Cleveland, Ohio, United States | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| Tulsa, Oklahoma, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Houston, Texas, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
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 May 19, 2013