Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Gestodene/EE Patch (BAY86-5016)

• Registration Number: NCT00910637
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-01
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Primary Completion: 2010-12-13
• Study Completion: 2010-12-13
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1502

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Gestodene/EE Patch (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
Occurrence of pregnancy (yes/no) while on treatment	13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcome Measures

Name	Time	Method
Physical and gynecological examinations	13 treatment cycles each consisting of 28 days
Vital signs	13 treatment cycles each consisting of 28 days
Adverse events (AE monitoring)	13 treatment cycles each consisting of 28 days
Laboratory assessments	13 treatment cycles each consisting of 28 days

Trial Locations

Locations (14)

Rosemark Women Care Specialist; 🇺🇸 Idaho Falls, Idaho, United States

Advances in Health, inc.; 🇺🇸 Houston, Texas, United States

The Woman's Hospital of Texas; 🇺🇸 Houston, Texas, United States

Women's Clinical Research Center; 🇺🇸 Seattle, Washington, United States

Genesis Center for Clinical Research; 🇺🇸 San Diego, California, United States

Office of Dr. R. Garn Mabey, MD; 🇺🇸 Las Vegas, Nevada, United States

Precision Trials; 🇺🇸 Phoenix, Arizona, United States

Visions Clinical Research - Tucson; 🇺🇸 Tucson, Arizona, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

Meridien Research; 🇺🇸 Saint Petersburg, Florida, United States

Research Associates; 🇺🇸 Boise, Idaho, United States

York Clinical Consulting; 🇺🇸 Oklahoma City, Oklahoma, United States

Practice Research Organization; 🇺🇸 Dallas, Texas, United States

Women's Care Center, PLC; 🇺🇸 Memphis, Tennessee, United States