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

• Status: Completed
• Trial end date: 2016-07-07
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Levonorgestrel

Criteria

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