EU/LA Pearl Index Study - Transdermal Contraceptive Patch

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00914693
First received: May 5, 2009
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Contraception
Drug: Ethinylestradiol/Gestodene (BAY86-5016)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Occurrence of pregnancy [ Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cervical smear [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]
  • Bleeding pattern and cycle control [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Treatment compliance [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: No ]
  • Subjective assessment of satisfaction with the treatment [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: No ]

Enrollment: 1694
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914693

  Show 66 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00914693     History of Changes
Other Study ID Numbers: 91554, 2008-004214-27, 310801
Study First Received: May 5, 2009
Last Updated: December 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Italy: The Italian Medicines Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Ministry of Health
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayer:
Fertility control
Contraception

Additional relevant MeSH terms:
Contraceptive Agents
Femovan
Gestodene
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Progestins

ClinicalTrials.gov processed this record on July 22, 2014