Inhibition of Ovulation and Pharmacokinetics of Transderm... | NCT00915915

Studies
Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

NCT00915915

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 28, 2014Estimated

Enrollment

108Actual

Phase

Phase 2

Conditions

Contraception
Ovulation Inhibition

Interventions

Ethinylestradiol/Gestodene (BAY86-5016)
Ethinylestradiol/Gestodene (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
2009-009177-10	EudraCT Number

Status Module

Record Verification Date

Oct 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

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

May 18, 2009

First Submission Date that Met QC Criteria

Jun 5, 2009

First Posted Date

Jun 8, 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

Oct 27, 2014

Last Update Posted Date

Oct 28, 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

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

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

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Ethinylestradiol/Gestodene (BAY86-5016)
Arm 2	Experimental		Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethinylestradiol/Gestodene (BAY86-5016)	Drug	Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3		4 months

Secondary Outcomes

Measure	Description	Time Frame
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3		4 months
Course of gonadotropins (FSH, LH, P, E2)		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI: 18 BMI 30 kg/m²
Healthy female volunteers
Age 18-35 years (smoker not older than 30 years, inclusive)
Ovulatory pre-treatment cycle, at least 3 month since delivery
Abortion or lactation before the first screening examination
Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
Regular intake of medication other than OCs
Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

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	10115	Germany

References Module

Citations

Not provided

ID	Term
D004997	Ethinyl Estradiol
C033273	Gestodene

ID	Term
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids