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

Phase 2

Completed

• Conditions: Female Sexual Dysfunction
• Interventions: Drug: PF-00446687; Drug: Placebo

• Registration Number: NCT00479570
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Study Start: 2007-06
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study period 1, 2 or 3	PF-00446687	-
Placebo Study period 1, 2 or 3	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	From day of dosing until 7 days post-dose

Secondary Outcome Measures

Name	Time	Method
Assess effect of single doses on medium term (1 week) sexual arousal and interest.	Until 7 days post-dose
Assess variability of response and repeatability of design between 2 similar doses.	Comparison of response to be assessed until 7 days post dose
If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.	Day of dosing
Assess PK , safety and toleration on day 1 of each study period.	Day of dosing

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Danderyd, Sweden