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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study period 1, 2 or 3 | Experimental |
| |
| Placebo Study period 1, 2 or 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00446687 | Drug | Single 200mg dose |
| |
| Placebo |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kobenhavn OE | 2100 | Denmark | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C549342 | 1-((1-tert-butyl-4-(2,4-difluorophenyl)pyrrolidin-3-yl)carbonyl)-3,5-dimethyl-4-phenylpiperidin-4-ol |
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| Drug |
|
| 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 |
| Oslo |
| Norway |
| Pfizer Investigational Site | Danderyd | S-182 88 | Sweden |