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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988910
First Posted: October 2, 2009
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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
Contraception 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 ]
  • Sexual well-being evaluated by the Female Sexual Function Index (FSFI) [ Time Frame: at 12 months ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women using Combined Oral Contraceptive (COC)
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988910


Locations
Italy
Many Locations, Italy
Sponsors and Collaborators
Bayer
Investigators
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 ( Other Identifier: Other company ID )
First Submitted: October 1, 2009
First Posted: October 2, 2009
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Bayer:
Combined Oral Contraceptives
COC

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female