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

• Sponsor: Medicines360 (Other)
• Overall Status: Completed
• CT.gov ID: NCT00995150
• Collaborator: (none)
• Enrollment: 1,910
• Locations: 25
• Arms: 2
• Actual Duration (Months): 143.3
• Patients Per Site: 76.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

• Study Type: Interventional
• 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
• Actual Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Oct 12, 2021
• Actual Study Completion Date: Oct 12, 2021

Arms and Interventions

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

Primary Outcome Measures

1. The primary efficacy of LNG20 will be assessed by pregnancy rates [10 years]

Secondary Outcome Measures

1. Adverse event [10 Years]

2. Levonorgestrel levels [10 Years]

3. Fertility rates one year following removal of the IUS [10 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Palo Alto	California	United States
3		San Francisco	California	United States
4		Vista	California	United States
5		Denver	Colorado	United States
6		Atlanta	Georgia	United States
7		Idaho Falls	Idaho	United States
8		Chicago	Illinois	United States
9		Des Moines	Iowa	United States
10		Ann Arbor	Michigan	United States
11		Saint Louis	Missouri	United States
12		New York	New York	United States
13		Chapel Hill	North Carolina	United States
14		Cincinnati	Ohio	United States
15		Cleveland	Ohio	United States
16		Columbus	Ohio	United States
17		Tulsa	Oklahoma	United States
18		Portland	Oregon	United States
19		Philadelphia	Pennsylvania	United States
20	Magee Women's Hospital, University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
21		Dallas	Texas	United States
22		Houston	Texas	United States
23		Salt Lake City	Utah	United States
24		Norfolk	Virginia	United States
25		Seattle	Washington	United States

Sponsors and Collaborators

• Medicines360

Investigators

• Study Director: Andrea Olariu, MD, PhD, COO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medicines360
• ClinicalTrials.gov Identifier: NCT00995150
• Other Study ID Numbers: M360-L102
• First Posted: Oct 15, 2009
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medicines360: contraception; intrauterine; long-term; reversible
• Additional relevant MeSH terms: Levonorgestrel

Study Results

No Results Posted as of Aug 9, 2022