Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women
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
1 other identifier
interventional
1,471
2 countries
100
Brief Summary
Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2015
Shorter than P25 for phase_3
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
May 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2016
CompletedApril 8, 2021
April 1, 2021
1.1 years
March 26, 2015
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy rate (Pearl Index)
Pearl Index = Number of pregnancies per 100 woman-years of exposure
Up to 12 months
Secondary Outcomes (1)
Cumulative failure rate
Up to 12 months
Study Arms (1)
Levonorgestrel (BAY98-7196)
EXPERIMENTALVaginal ring containing 170 mg levonorgestrel
Interventions
Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (100)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Mesa, Arizona, 85209, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Sacramento, California, 95821, United States
Unknown Facility
Sacramento, California, 95822, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Denver, Colorado, 80220, United States
Unknown Facility
New London, Connecticut, 06320, United States
Unknown Facility
Clearwater, Florida, 33759, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Lake Worth, Florida, 33461, United States
Unknown Facility
Leesburg, Florida, 34748, United States
Unknown Facility
Miami, Florida, 33186, United States
Unknown Facility
Miami Beach, Florida, 33141, United States
Unknown Facility
North Miami, Florida, 33161, United States
Unknown Facility
Oviedo, Florida, 32765, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Roswell, Georgia, 30075, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Champaign, Illinois, 61820, United States
Unknown Facility
Chicago, Illinois, 60610, United States
Unknown Facility
Shawnee Mission, Kansas, 66218, United States
Unknown Facility
Wichita, Kansas, 67207, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Kansas City, Missouri, 64114, United States
Unknown Facility
Lincoln, Nebraska, 68510, United States
Unknown Facility
Las Vegas, Nevada, 89104, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Las Vegas, Nevada, 89128, United States
Unknown Facility
Lawrenceville, New Jersey, 08648, United States
Unknown Facility
New Brunswick, New Jersey, 08901, United States
Unknown Facility
Albuquerque, New Mexico, 87109, United States
Unknown Facility
Johnson City, New York, 13790, United States
Unknown Facility
Port Jefferson, New York, 11777, United States
Unknown Facility
Rochester, New York, 14618, United States
Unknown Facility
Williamsville, New York, 14221, United States
Unknown Facility
Cary, North Carolina, 27518, United States
Unknown Facility
Charlotte, North Carolina, 28209, United States
Unknown Facility
Durham, North Carolina, 27713, United States
Unknown Facility
Greensboro, North Carolina, 27408, United States
Unknown Facility
New Bern, North Carolina, 28562, United States
Unknown Facility
Raleigh, North Carolina, 27607, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Salisbury, North Carolina, 28144, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45267-0457, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Columbus, Ohio, 43213, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15206, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Myrtle Beach, South Carolina, 29572, United States
Unknown Facility
Summerville, South Carolina, 29485, United States
Unknown Facility
Jackson, Tennessee, 38305-3618, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Draper, Utah, 84020, United States
Unknown Facility
Pleasant Grove, Utah, 84107, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Richmond, Virginia, 23233, United States
Unknown Facility
Virginia Beach, Virginia, 23456, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Spokane, Washington, 99207, United States
Unknown Facility
Funabashi, Chiba, 274-0071, Japan
Unknown Facility
Yotsukaidō, Chiba, 284-0001, Japan
Unknown Facility
Aki-gun, Hiroshima, 735-0029, Japan
Unknown Facility
Sapporo, Hokkaido, 004-0004, Japan
Unknown Facility
Sapporo, Hokkaido, 060-0807, Japan
Unknown Facility
Kurashiki, Okayama-ken, 710-0824, Japan
Unknown Facility
Chuo-ku, Tokyo, 104-0061, Japan
Unknown Facility
Hachiōji, Tokyo, 192-0046, Japan
Unknown Facility
Nakano-ku, Tokyo, 165-0032, Japan
Unknown Facility
Nishitōkyō, Tokyo, 188-0011, Japan
Unknown Facility
Ōta-ku, Tokyo, 144-0052, Japan
Unknown Facility
Setagaya-ku, Tokyo, 156-0042, Japan
Unknown Facility
Shinjuku, Tokyo, 162-0053, Japan
Unknown Facility
Toshima-ku, Tokyo, 171-0021, Japan
Unknown Facility
Fukui, 910-0845, Japan
Unknown Facility
Fukui, 910-0858, Japan
Unknown Facility
Fukui, 910-8561, Japan
Unknown Facility
Fukuoka, 813-0017, Japan
Unknown Facility
Osaka, 530-0013, Japan
Unknown Facility
Osaka, 542-0081, Japan
Unknown Facility
Osaka, 542-0086, Japan
Related Publications (1)
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.
PMID: 32914172DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
March 31, 2015
Study Start
May 15, 2015
Primary Completion
July 7, 2016
Study Completion
July 7, 2016
Last Updated
April 8, 2021
Record last verified: 2021-04