check_circleStudy Completed

Contraception

Bayer Identifier:

14182

ClinicalTrials.gov Identifier:

NCT00988910

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effects of drospirenone-containing or -not containing combined oral contraceptives on general and sexual well-being

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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
  • - Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)

Trial summary

Enrollment Goal
632
Trial Dates
January 2008 - December 2010
Phase
N/A
Could I Receive a placebo
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Italy

Primary Outcome

  • Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Sexual well-being evaluated by the Female Sexual Function Index (FSFI)
    date_rangeTime Frame:
    at 12 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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