Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction

Pfizer

Status and phase

Completed

Phase 2

Conditions

Erectile Dysfunction

Treatments

Drug: PF-00446687

Drug: Placebo

Drug: Sildenafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00862888

A8361011

Details and patient eligibility

About

The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.

Enrollment

39 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 with a history of significant cardiac disease; unstable angina or recent myocardial infarction.
Males suffering from treated or untreated hypo- or hypertension
Males currently receiving vasoactive medication
Males taking medications contraindicated, or cautioned with sildenafil or MC4 agonists

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

39 participants in 2 patient groups, including a placebo group

Cohort 1; Study Period 1, 2, 3 or 4

Placebo Comparator group

Description:

Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)

Treatment:

Drug: PF-00446687

Drug: Placebo

Drug: Sildenafil

Drug: PF-00446687

Drug: Sildenafil

Drug: PF-00446687

Drug: Placebo

Drug: PF-00446687

Cohort 2; study periods 1, 2, 3 or 4

Placebo Comparator group

Description:

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).

Treatment:

Drug: PF-00446687

Drug: Placebo

Drug: Sildenafil

Drug: PF-00446687

Drug: Sildenafil

Drug: PF-00446687

Drug: Placebo

Drug: PF-00446687