Transdermal Contraceptive Patch - Endometrial Effects Study | NCT00896571

Studies
Transdermal Contraceptive Patch - Endometrial Effects Study

NCT00896571

Sponsor

Bayer

Status

Completed

Last Update Posted

Nov 26, 2014Estimated

Enrollment

92Actual

Phase

Phase 2

Conditions

Contraception

Interventions

Ethinylestradiol/Gestogene (BAY86-5016)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-010599-45	EudraCT Number

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

May 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

May 8, 2009

First Submission Date that Met QC Criteria

May 8, 2009

First Posted Date

May 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2014

Last Update Posted Date

Nov 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Ethinylestradiol/Gestogene (BAY86-5016)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethinylestradiol/Gestogene (BAY86-5016)	Drug	7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect on the endometrium at cycle 13		13 treatment cycles (each consisting of 28 days)

Secondary Outcomes

Measure	Description	Time Frame
Cervical smear		13 treatment cycles (each consisting of 28 days)
Adverse events		13 treatment cycles (each consisting of 28 days)
Cycle control

Other Outcomes

Measure	Description	Time Frame
Treatment compliance		13 treatment cycles (each consisting of 28 days)
Subjective assessment of satisfaction with the treatment		13 treatment cycles (each consisting of 28 days)

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Berlin	State of Berlin	10629	Germany

Label	URL
Click here and search for EMA websynopsis result	View source

Intervention Browse Module

MeSH Terms

ID	Term
D004997	Ethinyl Estradiol

Ancestor Terms

ID	Term
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided