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

NCT ID: NCT00988910

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

632 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

EE30-DRSP (Yasmin, BAY86-5131)

Intervention Type DRUG

DRSP-containing combined oral contraceptives according to the normal routine praxis

Group 2

Other combined oral contraceptives

Intervention Type DRUG

Other combined oral contraceptives according to the normal routine praxis

Interventions

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EE30-DRSP (Yasmin, BAY86-5131)

DRSP-containing combined oral contraceptives according to the normal routine praxis

Intervention Type DRUG

Other combined oral contraceptives

Other combined oral contraceptives according to the normal routine praxis

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Italy

Site Status

Countries

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Italy

Other Identifiers

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YA0711IT

Identifier Type: OTHER

Identifier Source: secondary_id

14182

Identifier Type: -

Identifier Source: org_study_id

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