Clinical trial NCT02403401: Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Pregnancy prevention
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 1471
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy rate (Pearl Index)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Cumulative failure rate
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: La Mesa
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New London
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Champaign
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Shawnee Mission
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Lutherville
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Johnson City
country: United States
state: New York
city: Port Jefferson
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Summerville
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Draper
country: United States
state: Utah
city: Pleasant Grove
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Funabashi
country: Japan
state: Chiba
city: Yotsukaido
country: Japan
state: Chiba
city: Aki-gun
country: Japan
state: Hiroshima
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kurashiki
country: Japan
state: Okayama
city: Chuo-ku
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Nakano-ku
country: Japan
state: Tokyo
city: Nishitokyo
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Fukui
country: Japan
city: Fukui
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.