Effects of Drospirenone-Containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-Being
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: EE30-DRSP (Yasmin, BAY86-5131) (Drug); Other combined oral contraceptives (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
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
Study design: Cohort, Prospective
Primary outcome: Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)Sexual well-being evaluated by the Female Sexual Function Index (FSFI)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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)
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Italy; Recruiting
Additional Information
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Starting date: January 2008
Ending date: September 2009
Last updated: October 1, 2009
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