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



Status:Recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 35
Updated:4/21/2016
Start Date:May 2015
End Date:June 2017
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayerhealthcare.com

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Multi-center, Open-label, Single-arm Study to Assess the Safety and Contraceptive Efficacy of a Levonorgestrel-containing Intravaginal Ring During a Treatment Period of One Year in Healthy Women 18 to 35 Years of Age

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


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
We found this trial at
85
sites
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Jackson, TN
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Charlotte, North Carolina 28207
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Funabashi,
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Greensboro, North Carolina 27401
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LawrenceVille, New Jersey 08648
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Mt. Pleasant, South Carolina 29464
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Myrtle Beach, South Carolina 29572
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Salisbury, North Carolina 28144
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Wilmington, North Carolina 28401
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