Trial Condition(s):
Contraception
Effects of drospirenone-containing or -not containing combined oral contraceptives on general and sexual well-being (COSME)
Bayer Identifier:
14182
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)Timeframe: at 12 months
- Sexual well-being evaluated by the Female Sexual Function Index (FSFI)Timeframe: at 12 months
Additional Information
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