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

Female Sexual Dysfunction Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479570
• Other study ID #: A8361015
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: January 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

Drug:
• PF-00446687
Single 200mg dose
• Placebo

Locations

Country	Name	City	State
Denmark	Pfizer Investigational Site	Kobenhavn OE
Norway	Pfizer Investigational Site	Oslo
Sweden	Pfizer Investigational Site	Danderyd

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

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

External Links

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