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OpenTrials
Completed

NCT Number: NCT00988910

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

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.

Completed

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EE30-DRSP (Yasmin, BAY86-5131)

Drug

DRSP-containing combined oral contraceptives according to the normal routine praxis

Other combined oral contraceptives

Drug

Other combined oral contraceptives according to the normal routine praxis

Primary outcomes

  1. Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)

    Time frame: at 12 months

  2. Sexual well-being evaluated by the Female Sexual Function Index (FSFI)

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: COSME

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 2, 2009
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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