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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910637
• Other study ID #: 91555
• Secondary ID: 310802
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2009
• Est. completion date: December 13, 2010

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1502
• Est. completion date: December 13, 2010
• Est. primary completion date: December 13, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Gestodene/EE Patch (BAY86-5016)
55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles

Locations

Country	Name	City	State
United States	Research Associates	Boise	Idaho
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Practice Research Organization	Dallas	Texas
United States	Advances in Health, inc.	Houston	Texas
United States	The Woman's Hospital of Texas	Houston	Texas
United States	Rosemark Women Care Specialist	Idaho Falls	Idaho
United States	Office of Dr. R. Garn Mabey, MD	Las Vegas	Nevada
United States	Women's Care Center, PLC	Memphis	Tennessee
United States	York Clinical Consulting	Oklahoma City	Oklahoma
United States	Precision Trials	Phoenix	Arizona
United States	Meridien Research	Saint Petersburg	Florida
United States	Genesis Center for Clinical Research	San Diego	California
United States	Women's Clinical Research Center	Seattle	Washington
United States	Visions Clinical Research - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of pregnancy (yes/no) while on treatment		13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary	Vital signs		13 treatment cycles each consisting of 28 days
Secondary	Physical and gynecological examinations		13 treatment cycles each consisting of 28 days
Secondary	Laboratory assessments		13 treatment cycles each consisting of 28 days
Secondary	Adverse events (AE monitoring)		13 treatment cycles each consisting of 28 days

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