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PF-00446687 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1; Study Period 1, 2, 3 or 4 | PLACEBO_COMPARATOR | Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design) |
| Cohort 2; study periods 1, 2, 3 or 4 | PLACEBO_COMPARATOR | Cohort 2: Exploring single doses of PF-00446687 20 mg - 175 mg. Subjects to receive two of 3 possible doses of PF-00446687 as well as a single dose of sildenafil 100mg and placebo (double dummy design). |
| Study period 1, 2 or 3 | EXPERIMENTAL | - |
| Placebo Study period 1, 2 or 3 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-00446687 | DRUG | Single 200mg dose as an oral solution |
| Placebo | DRUG | Placebo for oral solution |
| Sildenafil | DRUG | Single oral dose 100 mg tablet |
Inclusion Criteria: * Males aged 18-65 years who has given written informed consent to participate in the study and who suffers moderate to severe erectile dysfunction who has a current or recent successful response to treatment with phosphodiesterase type 5 inhibitors Exclusion Criteria: * Males...
PF-00446687 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for sexual dysfunction indications. It has been studied in Phase 2 clinical trials for erectile dysfunction in men and for female sexual dysfunction in post-menopausal women. It is not an approved medicine and remains in clinical development.
PF-00446687 has been studied for two indications: erectile dysfunction in men and female sexual dysfunction in post-menopausal women. Both were evaluated in Phase 2 trials. The drug is investigational and has not been approved for any use.
PF-00446687 targets MC4R, the melanocortin 4 receptor, and acts as an agonist at that receptor. MC4R is a G protein-coupled receptor involved in melanocortin signaling. This receptor agonist mechanism is the basis for its investigation in erectile dysfunction and female sexual dysfunction.
PF-00446687 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 2 clinical studies of the compound in erectile dysfunction and female sexual dysfunction.
PF-00446687 is in Phase 2 development. Two Phase 2 trials have been completed, one in men with erectile dysfunction and one in post-menopausal women with sexual dysfunction. The drug is investigational and has not been approved by the FDA.
PF-00446687 has been studied in two completed Phase 2 trials. NCT00862888 tested it in 39 men with erectile dysfunction in Norway and the United Kingdom. NCT00479570 tested it in 23 post-menopausal women with sexual dysfunction in Denmark, Norway, and Sweden. Both were randomized, double-blind, and placebo-controlled.