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

Bayer

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: Levonorgestrel (BAY98-7196)

Study type

Interventional

Funder types

Industry

Identifiers

16803

Details and patient eligibility

About

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

Enrollment

1,471 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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