Trial Condition(s):
Contraception
Safety and contraceptive efficacy of an intravaginal ring with LNG (levonorgestrel) over one year in healthy women
Bayer Identifier:
16803
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Sapporo, Japan, 060-0807 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yotsukaido, Japan, 284-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ota-ku, Japan, 144-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Setagaya-ku, Japan, 156-0042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku, Japan, 162-0053 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nakano-ku, Japan, 165-0032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hachioji, Japan, 192-0046 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 530-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 542-0086 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukui, Japan, 910-0845 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukui, Japan, 910-0858 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukui, Japan, 910-8561 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 813-0017 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sapporo, Japan, 004-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toshima-ku, Japan, 171-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nishitokyo, Japan, 188-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Funabashi, Japan, 274-0071 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 542-0081 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kurashiki, Japan, 710-0824 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aki-gun, Japan, 735-0029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15206 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, United States, 32765 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wilmington, United States, 28401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site North Miami, United States, 33161 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shawnee, United States, 66218 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salt Lake City, United States, 84107 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rochester, United States, 14618 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chandler, United States, 85224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Port Jefferson, United States, 11777 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Williamsville, United States, 14221 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mesa, United States, 85209 | Status Completed | Contact Us: E-mail: clin[email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mobile, United States, 36608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Little Rock, United States, 72205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leesburg, United States, 34748 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32216 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roswell, United States, 30075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jupiter, United States, 33458 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lawrenceville, United States, 08648 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pleasant Grove, United States, 84107 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30342 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Brunswick, United States, 08901 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Raleigh, United States, 27612 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denver, United States, 80220 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corpus Christi, United States, 78414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jackson, United States, 38305-3618 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wellington, United States, 33414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Myrtle Beach, United States, 29572 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wichita, United States, 67207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lake Worth, United States, 33461 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Bern, United States, 28562 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salisbury, United States, 28144 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Virginia Beach, United States, 23456 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charlotte, United States, 28209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Idaho Falls, United States, 83404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cary, United States, 27518 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Mesa, United States, 91942 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New London, United States, 06320 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mt. Pleasant, United States, 29464 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45267-0457 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Champaign, United States, 61820 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denver, United States, 80218 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sacramento, United States, 95821 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lutherville, United States, 21093 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Summerville, United States, 29485 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami Beach, United States, 33141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lincoln, United States, 68510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Draper, United States, 84020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clearwater, United States, 33759 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33186 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johnson City, United States, 13790 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sacramento, United States, 95822 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, United States, 33709 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kansas City, United States, 64114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbia, United States, 29201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27713 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Raleigh, United States, 27607 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greensboro, United States, 27408 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Pregnancy rate (Pearl Index)Pearl Index = Number of pregnancies per 100 woman-years of exposureTimeframe: Up to 12 months
Secondary Outcome
- Cumulative failure rateProbability of getting pregnantTimeframe: Up to 12 months
Additional Information
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