| May 24, 2007 |
| April 7, 2009 |
| June 2007 |
| February 2008 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| 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. |
| Complete list of historical versions of study NCT00479570 on ClinicalTrials.gov Archive Site |
- Assess effect of single doses on medium term (1 week) sexual arousal and interest. [ Time Frame: Until 7 days post-dose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period. [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]
- Assess PK , safety and toleration on day 1 of each study period. [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]
|
- Assess effect of single doses on medium term (1 week) sexual arousal and interest.
- Assess variability of response and repeatability of design between 2 similar doses. Assess PK , safety and toleration on day 1 of each study period.
- If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period
|
| |
| 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). |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
| Female Sexual Dysfunction |
- Drug: PF-00446687
- Drug: Placebo
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| |
| |
| |
| Completed |
| 23 |
| February 2008 |
| February 2008 (final data collection date for primary outcome measure) |
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.
|
| Female |
| 45 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Denmark, Norway, Sweden |
| |
| NCT00479570 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A8361015 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| April 2009 |
