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

Completed · Phase 3

Conditions studied: Contraception

In brief

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

Key facts

Study ID

NCT02403401

Run by

Bayer

People needed

1471

Starts

2015-05-15

Expected to finish

2016-07-07

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — La Mesa, California, United States
• Study site — Sacramento, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — New London, Connecticut, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Lake Worth, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Oviedo, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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