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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 1, 2009
Last updated: June 25, 2014
Last verified: June 2014
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.

Condition Intervention
Drug: EE30-DRSP (Yasmin, BAY86-5131)
Drug: Other combined oral contraceptives

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Sexual well-being evaluated by the Female Sexual Function Index (FSFI) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Enrollment: 632
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: EE30-DRSP (Yasmin, BAY86-5131)
DRSP-containing combined oral contraceptives according to the normal routine praxis
Group 2 Drug: Other combined oral contraceptives
Other combined oral contraceptives according to the normal routine praxis


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women using Combined Oral Contraceptive (COC)

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00988910

Many Locations, Italy
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00988910     History of Changes
Other Study ID Numbers: 14182  YA0711IT 
Study First Received: October 1, 2009
Last Updated: June 25, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Bayer:
Combined Oral Contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2016