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: December 14, 2016

Last verified: December 2016

History of Changes

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 for up to 8 years.

Condition	Intervention	Phase
Contraception	Drug: LNG20 Drug: Mirena	Phase 3


Study Type:	Interventional
Study Design:	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

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: 8 years ]

Secondary Outcome Measures:

Adverse event [ Time Frame: 8 Years ]
Levonorgestrel levels [ Time Frame: 8 Years ]
Fertility rates one year following removal of the IUS [ Time Frame: 8 Years ]


Enrollment:	1910
Study Start Date:	November 2009
Estimated Study Completion Date:	December 2021
Estimated Primary Completion Date:	December 2020 (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

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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995150

Show 27 Study Locations

Sponsors and Collaborators

Medicines360

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD; ACCESS IUS Investigators. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015 Jul;92(1):10-6. doi: 10.1016/j.contraception.2015.04.006. Epub 2015 Apr 28.


Responsible Party:	Medicines360
ClinicalTrials.gov Identifier:	NCT00995150 History of Changes
Other Study ID Numbers:	M360-L102
Study First Received:	October 13, 2009
Last Updated:	December 14, 2016
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

ClinicalTrials.gov processed this record on August 18, 2017

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