Effects of Drospirenone-containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-being (COSME)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00988910
First received: October 1, 2009
Last updated: April 14, 2010
Last verified: April 2010
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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:
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
More Information
Additional Information:
No publications provided
Keywords provided by Bayer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
Additional Information:
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 October 17, 2012