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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:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00988910
First received: October 1, 2009
Last updated: April 14, 2010
Last verified: April 2010
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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 ]

Estimated Enrollment: 600
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: November 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

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)

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988910

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

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00988910     History of Changes
Other Study ID Numbers: 14182, YA0711IT
Study First Received: October 1, 2009
Last Updated: April 14, 2010
Health Authority: Italy: Ethics Committee

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
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 19, 2013