Clinical trial NCT00910637: Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles
Official title: Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Pregnancy prevention
Female contraception
Patch
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 1502
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is examining a birth control patch for 13 cycles (1 year).


Eligibility criteria: Inclusion Criteria:

* Requiring contraception
* Normal cervical smear
* Maximum age for smokers is 35
* History of regular cyclic menstrual periods

Exclusion Criteria:

* Pregnancy or lactation
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication

Primary outcomes:
measure: Occurrence of pregnancy (yes/no) while on treatment
timeFrame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcomes:
measure: Vital signs
timeFrame: 13 treatment cycles each consisting of 28 days
measure: Physical and gynecological examinations
timeFrame: 13 treatment cycles each consisting of 28 days
measure: Laboratory assessments
timeFrame: 13 treatment cycles each consisting of 28 days
measure: Adverse events (AE monitoring)
timeFrame: 13 treatment cycles each consisting of 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Carmichael
country: United States
state: California
city: Pacific Palisades
country: United States
state: California
city: Paramount
country: United States
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: New London
country: United States
state: Connecticut
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Boise
country: United States
facility: Research Associates
state: Idaho
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialist
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Newburgh
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Marrero
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Chaska
country: United States
state: Minnesota
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
facility: Office of Dr. R. Garn Mabey, MD
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: Moorestown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: New Bern
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: Oklahoma City
country: United States
facility: York Clinical Consulting
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
facility: Women's Care Center, PLC
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
facility: Practice Research Organization
state: Texas
city: Houston
country: United States
facility: Advances in Health, inc.
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: