Transdermal Contraceptive Patch - Endometrial Effects Study

Contraception Clinical Trial

Official title:

Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896571
• Other study ID #: 14287
• Secondary ID: 2009-010599-45
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2009
• Last updated: November 24, 2014
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Requiring contraception

• Normal cervical smear

• Smokers not older than 30 years

• History of regular cyclic menstrual periods

Exclusion Criteria:

• Pregnancy or lactation

• Obesity (BMI> 30 kg/m2)

• 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Ethinylestradiol/Gestogene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment compliance		13 treatment cycles (each consisting of 28 days)	No
Other	Subjective assessment of satisfaction with the treatment		13 treatment cycles (each consisting of 28 days)	No
Primary	Effect on the endometrium at cycle 13		13 treatment cycles (each consisting of 28 days)	No
Secondary	Cervical smear		13 treatment cycles (each consisting of 28 days)	Yes
Secondary	Adverse events		13 treatment cycles (each consisting of 28 days)	Yes
Secondary	Cycle control		13 treatment cycles (each consisting of 28 days)	No
Secondary	Safety laboratory		13 treatment cycles (each consisting of 28 days)	Yes
Secondary	Occurence of pregnancy		13 treatment cycles (each consisting of 28 days)	Yes

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