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Completed

NCT Number: NCT00479570

Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.

The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.

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Key information

Conditions

Female Sexual Dysfunction

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Kobenhavn OE, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women who have evidence of Female Sexual Arousal Disorder.
  • Women who experience personal distress due to Female Sexual Dysfunction.
  • Post menopausal women aged between 45 and 65 years.

Exclusion criteria

  • Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
  • Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
  • Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.

Treatment and study plan

PF-00446687

Drug

Single 200mg dose

Placebo

Drug

Primary outcomes

  1. Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days.

    Time frame: From day of dosing until 7 days post-dose

Secondary outcomes

  1. Assess effect of single doses on medium term (1 week) sexual arousal and interest.

    Time frame: Until 7 days post-dose

  2. Assess variability of response and repeatability of design between 2 similar doses.

    Time frame: Comparison of response to be assessed until 7 days post dose

  3. If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.

    Time frame: Day of dosing

  4. Assess PK , safety and toleration on day 1 of each study period.

    Time frame: Day of dosing

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 28, 2007
Registry last updated
Jan 31, 2019

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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