Effects of Drospirenone-containing or -Not Containing Com... | NCT00988910

Studies
Effects of Drospirenone-containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-being

NCT00988910

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 26, 2014Estimated

Enrollment

632Actual

Phase

Not provided

Conditions

Contraception

Interventions

EE30-DRSP (Yasmin, BAY86-5131)
Other combined oral contraceptives

Countries

Italy

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
YA0711IT	Other Identifier	Other company ID

Status Module

Record Verification Date

Jun 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

Jan 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 1, 2009

First Submission Date that Met QC Criteria

Oct 1, 2009

First Posted Date

Oct 2, 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

Jun 25, 2014

Last Update Posted Date

Jun 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 purpose of this study is to evaluate the symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

632Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: EE30-DRSP (Yasmin, BAY86-5131)
Group 2			Drug: Other combined oral contraceptives

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EE30-DRSP (Yasmin, BAY86-5131)	Drug	DRSP-containing combined oral contraceptives according to the normal routine praxis	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)		at 12 months
Sexual well-being evaluated by the Female Sexual Function Index (FSFI)		at 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

According to the label of the prescribed Combined Oral Contraceptive (COC)
first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use
intention to use current COC for 1 year at least

Exclusion Criteria:

Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Healthy women using Combined Oral Contraceptive (COC)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
C534342	drospirenone and ethinyl estradiol combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided