Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel (BAY98-7196)

• Registration Number: NCT02403401
• Lead Sponsor: Bayer

Brief Summary

Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Study Start: 2015-05-15
• Primary Completion: 2016-07-07
• Study Completion: 2016-07-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1471

Inclusion Criteria

• Healthy female subject requesting contraception and willing to use the IVR
• Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
• History of regular cyclic menstrual periods
• Subject is willing and able to attend the scheduled study visits and comply with study procedures

Exclusion Criteria

• Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
• Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
• Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator
• Undiagnosed abnormal genital bleeding
• Wish for pregnancy during the study
• Major surgery scheduled during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levonorgestrel (BAY98-7196)	Levonorgestrel (BAY98-7196)	Vaginal ring containing 170 mg levonorgestrel

Primary Outcome Measures

Name	Time	Method
Pregnancy rate (Pearl Index)	Up to 12 months	Pearl Index = Number of pregnancies per 100 woman-years of exposure

Secondary Outcome Measures

Name	Time	Method
Cumulative failure rate	Up to 12 months	Probability of getting pregnant