check_circleStudy Completed

Contraception

Bayer Identifier:

16803

ClinicalTrials.gov Identifier:

NCT02403401

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and contraceptive efficacy of an intravaginal ring with LNG (levonorgestrel) over one year in healthy women

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
1471
Trial Dates
May 2015 - July 2016
Phase
Phase 3
Could I Receive a placebo
No
Products
Anastrozole and Levonorgestrel (BAY98-7196)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sapporo, 060-0807, Japan
Completed
Yotsukaido, 284-0001, Japan
Completed
Chuo-ku, 104-0061, Japan
Completed
Chuo-ku, 104-0061, Japan
Withdrawn
Minato-ku, 108-8642, Japan
Completed
Ota-ku, 144-0052, Japan
Completed
Setagaya-ku, 156-0042, Japan
Completed
Shinjuku, 162-0053, Japan
Completed
Nakano-ku, 165-0032, Japan
Completed
Hachioji, 192-0046, Japan
Withdrawn
Yokohama, 230-0001, Japan
Completed
Osaka, 530-0013, Japan
Completed
Osaka, 542-0086, Japan
Completed
Fukui, 910-0845, Japan
Completed
Fukui, 910-0858, Japan
Completed
Fukui, 910-8561, Japan
Completed
Fukuoka, 813-0017, Japan
Withdrawn
Kagoshima, 892-0816, Japan
Withdrawn
Asahikawa, 070-8003, Japan
Completed
Sapporo, 004-0004, Japan
Completed
Toshima-ku, 171-0021, Japan
Completed
Chuo-ku, 104-0061, Japan
Completed
Ota-ku, 144-0052, Japan
Completed
Nishitokyo, 188-0011, Japan
Withdrawn
Chiyoda-ku, 101-0062, Japan
Completed
Funabashi, 274-0071, Japan
Completed
Osaka, 542-0081, Japan
Completed
Kurashiki, 710-0824, Japan
Completed
Aki-gun, 735-0029, Japan
Withdrawn
Yanagawa, 832-0077, Japan
Withdrawn
Kagoshima, 890-0055, Japan
Completed
Baltimore, United States
Completed
Philadelphia, 19114, United States
Completed
Pittsburgh, 15206, United States
Completed
Oviedo, 32765, United States
Completed
Tucson, 85710, United States
Completed
Wilmington, 28401, United States
Completed
North Miami, 33161, United States
Completed
Shawnee, 66218, United States
Completed
Salt Lake City, 84107, United States
Withdrawn
Little Rock, 72205, United States
Completed
Rochester, 14618, United States
Completed
Chandler, 85224, United States
Completed
Port Jefferson, 11777, United States
Completed
Williamsville, 14221, United States
Completed
Houston, 77030, United States
Completed
Mesa, 85209, United States
Completed
Winston-Salem, 27103, United States
Completed
Mobile, 36608, United States
Completed
Chandler, 85224, United States
Completed
Chicago, 60610, United States
Completed
Little Rock, 72205, United States
Completed
Leesburg, 34748, United States
Completed
Jacksonville, 32216, United States
Completed
Winston-Salem, 27103, United States
Completed
Roswell, 30075, United States
Completed
Las Vegas, 89104, United States
Completed
Phoenix, 85032, United States
Completed
Jupiter, 33458, United States
Completed
Lawrenceville, 08648, United States
Completed
Albuquerque, 87109, United States
Withdrawn
Saginaw, 48604, United States
Completed
Pleasant Grove, 84107, United States
Completed
Atlanta, 30342, United States
Completed
New Brunswick, 08901, United States
Completed
Raleigh, 27612, United States
Completed
Denver, 80220, United States
Completed
San Diego, 92103, United States
Completed
Corpus Christi, 78414, United States
Completed
Jackson, 38305-3618, United States
Completed
Wellington, 33414, United States
Completed
San Antonio, 78229, United States
Completed
Las Vegas, 89109, United States
Completed
Myrtle Beach, 29572, United States
Completed
Wichita, 67207, United States
Completed
San Diego, 92108, United States
Completed
Seattle, 98105, United States
Completed
Lake Worth, 33461, United States
Completed
Las Vegas, 89128, United States
Completed
Spokane, 99207, United States
Completed
New Bern, 28562, United States
Completed
Salisbury, 28144, United States
Completed
Virginia Beach, 23456, United States
Completed
Charlotte, 28209, United States
Completed
San Diego, 92123, United States
Completed
Idaho Falls, 83404, United States
Completed
San Antonio, 78229, United States
Completed
Cary, 27518, United States
Completed
La Mesa, 91942, United States
Completed
New London, 06320, United States
Completed
Mt. Pleasant, 29464, United States
Completed
Cincinnati, 45267-0457, United States
Completed
Champaign, 61820, United States
Completed
Denver, 80218, United States
Completed
Sacramento, 95821, United States
Completed
Richmond, 23233, United States
Completed
Lutherville, 21093, United States
Completed
Summerville, 29485, United States
Completed
Columbus, 43213, United States
Completed
Miami Beach, 33141, United States
Completed
Lincoln, 68510, United States
Completed
Draper, 84020, United States
Completed
Clearwater, 33759, United States
Completed
Miami, 33186, United States
Completed
Johnson City, 13790, United States
Completed
Pittsburgh, 15213, United States
Completed
Sacramento, 95822, United States
Completed
St. Petersburg, 33709, United States
Completed
Cleveland, 44122, United States
Withdrawn
Annapolis, 21401, United States
Completed
Kansas City, 64114, United States
Completed
Columbia, 29201, United States
Completed
Houston, 77074, United States
Withdrawn
Tacoma, 98405, United States
Withdrawn
Newburgh, 47630, United States
Completed
Durham, 27713, United States
Completed
Raleigh, 27607, United States
Completed
Greensboro, 27408, United States
Completed
Greensboro, 27408, United States

Primary Outcome

  • Pregnancy rate (Pearl Index)
    Pearl Index = Number of pregnancies per 100 woman-years of exposure
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Cumulative failure rate
    Probability of getting pregnant
    date_rangeTime Frame:
    Up to 12 months

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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