Clinical trial NCT00920985: US Cycle Control and Blood Pressure Study
Official title: Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Pregnancy prevention
Female contraception
Patch
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 346
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Birth Control Patch Study


Eligibility criteria: Inclusion Criteria:

* Female subject requesting contraception
* Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
* Normal 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

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: Cycle control parameters and bleeding pattern indices
timeFrame: Treatment cycles 2-7
Secondary outcomes:
measure: Number of pregnancies while on treatment up to 14 days after removal of the last patch
timeFrame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
measure: Evaluation of blood pressure changes during the dosing-free interval
timeFrame: 7 treatment cycles each consisting of 28 days
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: San Diego
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Metairie
country: United States
state: Louisiana
city: Kalamazoo
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: New Brunswick
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Richmond
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: La Crosse
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Merz M, Kroll R, Lynen R, Bangerter K. Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study. Contraception. 2015 Feb;91(2):113-20. doi: 10.1016/j.contraception.2014.10.004. Epub 2014 Oct 13.