Transdermal Contraceptive Patch - Endometrial Effects Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Contraception	Drug: Ethinylestradiol/Gestogene (BAY86-5016)	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Ethinyl Estradiol

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Effect on the endometrium at cycle 13 [ Time Frame: 13 treatment cycles (each consisting of 28 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 ]
Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]

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:	92
Study Start Date:	July 2009
Study Completion Date:	August 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	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

Eligibility

Criteria

Inclusion Criteria:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896571

Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00896571 History of Changes
Other Study ID Numbers:	14287, 2009-010599-45
Study First Received:	May 8, 2009
Last Updated:	December 12, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Fertility control
Contraception

Additional relevant MeSH terms:

Contraceptive Agents
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 21, 2013