CompletedPhase 3

Effects of SH T00658ID on Libido

Australia217 participantsStarted 2009-01

Plain-language summary

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion Criteria: * OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon * Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline Exclusion Criteria: * Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease

What they're measuring

Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Trial details

NCT IDNCT00764881

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07

Results submitted2011-07-28

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