EU/LA Pearl Index Study - Transdermal Contraceptive Patch

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 (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914693
• Other study ID #: 91554
• Secondary ID: 2008-004214-2731
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2009
• Last updated: December 4, 2014
• Start date: April 2009
• Est. completion date: September 2011

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesItaly: The Italian Medicines AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaMexico: Ministry of HealthChile: Comisión Nacional de Investigación Científica y TecnológicaAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1694
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• 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: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Ethinylestradiol/Gestodene (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

Countries where clinical trial is conducted

Argentina,  Australia,  Chile,  France,  Germany,  Italy,  Mexico,  Spain, 

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	Occurrence of pregnancy		13 treatment cycles each consisting of 28 days and follow-up period of 14 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	Bleeding pattern and cycle control		13 treatment cycles each consisting of 28 days	No

External Links

•   Click here and search for Bayer Product information provided by EMA
•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer Healthcare products.