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

Observational Study on the Effects of DRSP-Containing Combined Oral Contraceptives (Yasmin,Yasminelle) and Other Combined Oral Contraceptives on the General and Sexual Well-Being in COC Users

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00988910

Acronym

COSME

Enrollment

632

Registered

2009-10-02

Start date

2008-01-31

Completion date

2010-12-31

Last updated

2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Combined Oral Contraceptives, COC

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.

Interventions

DRUGEE30-DRSP (Yasmin, BAY86-5131)

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

DRUGOther combined oral contraceptives

Other combined oral contraceptives according to the normal routine praxis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026