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

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
|
- The primary efficacy of LNG20 will be assessed by pregnancy rates [ Time Frame: 10 years ]
- Adverse event [ Time Frame: 10 Years ]
- Levonorgestrel levels [ Time Frame: 10 Years ]
- Fertility rates one year following removal of the IUS [ Time Frame: 10 Years ]

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Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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

Study Director: | Andrea Olariu, MD, PhD | Chief Medical Officer |
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 |