FC Patch Low: Metabolism Study | NCT00933179

Studies
FC Patch Low: Metabolism Study

NCT00933179

Sponsor

Bayer

Status

Completed

Last Update Posted

Nov 14, 2014Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Contraception

Interventions

Gestodene/EE Patch (BAY86-5016)
EE/Levonorgestrel (Microgynon, BAY86-4977)

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
2008-007024-26	EudraCT Number

Official Title

A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period

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

Jun 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jul 3, 2009

First Submission Date that Met QC Criteria

Jul 3, 2009

First Posted Date

Jul 7, 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 13, 2014

Last Update Posted Date

Nov 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism 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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Gestodene/EE Patch (BAY86-5016)
Arm 2	Active Comparator		Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gestodene/EE Patch (BAY86-5016)	Drug	21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prothrombin fragment 1+2, D-dimer		Screening, visit 3-7

Secondary Outcomes

Measure	Description	Time Frame
Procoagulatory parameters		Screening, visit 3-7
Anticoagulatory parameters		Screening, visit 3-7
Thrombin and Fibrin turnover parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy woman requesting contraception
Normal cervical smear not requiring further follow-up
History of regular cyclic menstrual periods
Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods

Exclusion Criteria:

Pregnancy or lactation - Obesity (Body Mass Index [BMI] > 30.0 kg/m2)
Any diseases or conditions that can compromise the function of the body systems
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
Any disease or condition that may worsen under hormonal treatment
Undiagnosed abnormal genital bleeding
Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

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

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Berlin	State of Berlin	10115	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24043457	Result	Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2.