US Cycle Control and Blood Pressure Study

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

Sponsors

Lead Sponsor: Bayer

Source Bayer
Brief Summary

Birth Control Patch Study

Overall Status Completed
Start Date June 2009
Completion Date September 2010
Primary Completion Date August 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Cycle control parameters and bleeding pattern indices Treatment cycles 2-7
Secondary Outcome
Measure Time Frame
Number of pregnancies while on treatment up to 14 days after removal of the last patch 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Evaluation of blood pressure changes during the dosing-free interval 7 treatment cycles each consisting of 28 days
Enrollment 346
Condition
Intervention

Intervention Type: Drug

Intervention Name: Gestodene/EE (FC Patch Low, BAY86-5016)

Description: 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2

Arm Group Label: Arm 1

Intervention Type: Drug

Intervention Name: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A

Description: 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1

Arm Group Label: Arm 2

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
Facility:
| Chandler, Arizona, 85225-2909, United States
| Glendale, Arizona, 85304, United States
| Phoenix, Arizona, 85032, United States
| Tucson, Arizona, 85712, United States
| Anaheim, California, 92801, United States
| San Diego, California, 92121, United States
| Clearwater, Florida, 33759, United States
| Daytona Beach, Florida, 32114, United States
| Lake Worth, Florida, 33461, United States
| Leesburg, Florida, 34748, United States
| Miami, Florida, 33169, United States
| Atlanta, Georgia, 30342, United States
| Decatur, Georgia, 30034, United States
| Metairie, Louisiana, 70006, United States
| Kalamazoo, Michigan, 49009, United States
| St. Louis, Missouri, 63141, United States
| Las Vegas, Nevada, 89104, United States
| New Brunswick, New Jersey, 08901, United States
| Winston-Salem, North Carolina, 27103, United States
| Cincinnati, Ohio, 45246, United States
| Philadelphia, Pennsylvania, 19114, United States
| Pittsburgh, Pennsylvania, 15206, United States
| Wexford, Pennsylvania, 15090, United States
| Columbia, South Carolina, 29201, United States
| Richmond, Virginia, 23294, United States
| Renton, Washington, 98055, United States
| Seattle, Washington, 98105, United States
| La Crosse, Wisconsin, 54691, United States
Location Countries

United States

Verification Date

January 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Arm 1

Type: Experimental

Label: Arm 2

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov