Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women
NCT02403401 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1471
Last updated 2021-04-08
Summary
Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.
Conditions
- Contraception
Interventions
- DRUG
-
Levonorgestrel (BAY98-7196)
Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-15
- Primary Completion
- 2016-07-07
- Completion
- 2016-07-07
- FDA Drug
- Yes
Countries
- United States
- Japan
Study Locations
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