Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women
NCT ID: NCT02403401
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1471 participants
INTERVENTIONAL
2015-05-15
2016-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Levonorgestrel (BAY98-7196)
Vaginal ring containing 170 mg levonorgestrel
Levonorgestrel (BAY98-7196)
Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)
Interventions
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Levonorgestrel (BAY98-7196)
Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Mobile, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
La Mesa, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
New London, Connecticut, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Lake Worth, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
North Miami, Florida, United States
Oviedo, Florida, United States
St. Petersburg, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Roswell, Georgia, United States
Idaho Falls, Idaho, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Shawnee Mission, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Lutherville, Maryland, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Lawrenceville, New Jersey, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Johnson City, New York, United States
Port Jefferson, New York, United States
Rochester, New York, United States
Williamsville, New York, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
New Bern, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Myrtle Beach, South Carolina, United States
Summerville, South Carolina, United States
Jackson, Tennessee, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
Pleasant Grove, Utah, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Funabashi, Chiba, Japan
Yotsukaidō, Chiba, Japan
Aki-gun, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kurashiki, Okayama-ken, Japan
Chuo-ku, Tokyo, Japan
Hachiōji, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Nishitōkyō, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shinjuku, Tokyo, Japan
Toshima-ku, Tokyo, Japan
Fukui, , Japan
Fukui, , Japan
Fukui, , Japan
Fukuoka, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Countries
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References
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Nave R, Hochel J, Mellinger U, Kohnke A, Elliesen J, Schmitz H. Pearl Index study with levonorgestrel-releasing intravaginal rings: using pharmacokinetic results to investigate treatment compliance as a potential contributor for contraceptive failure. Hum Reprod. 2020 Nov 1;35(11):2515-2523. doi: 10.1093/humrep/deaa195.
Related Links
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Other Identifiers
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16803
Identifier Type: -
Identifier Source: org_study_id
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