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

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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479570

Enrollment

Registered

2007-05-28

Start date

2007-06-30

Completion date

2008-02-29

Last updated

2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Sexual Dysfunction

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.

Interventions

DRUGPF-00446687

Single 200mg dose

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Denmark, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026