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

Contraception Clinical Trial

— COSME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988910
• Other study ID #: 14182
• Secondary ID: YA0711IT
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: June 25, 2014
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• EE30-DRSP (Yasmin, BAY86-5131)
DRSP-containing combined oral contraceptives according to the normal routine praxis
• Other combined oral contraceptives
Other combined oral contraceptives according to the normal routine praxis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)		at 12 months	No
Primary	Sexual well-being evaluated by the Female Sexual Function Index (FSFI)		at 12 months	No

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