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

Phase 2

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: PF-00446687; Drug: Placebo; Drug: Sildenafil

• Registration Number: NCT00862888
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-07
• Last Update Posted: 2009-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1; Study Period 1, 2, 3 or 4	PF-00446687	Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)
Cohort 1; Study Period 1, 2, 3 or 4	Placebo	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	PF-00446687	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).
Cohort 2; study periods 1, 2, 3 or 4	Placebo	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).
Cohort 2; study periods 1, 2, 3 or 4	Sildenafil	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).
Cohort 1; Study Period 1, 2, 3 or 4	Sildenafil	Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)

Primary Outcome Measures

Name	Time	Method
Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)	Day of dosing
Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire	Day of dosing
Diary of sexual activities	From day of dosing to 7 days post-dose

Secondary Outcome Measures

Name	Time	Method
PK assessment of PF-00446687 ad sildenafil	Day of dosing
Safety and toleration	Day of dosing to follow-up
Assess variability of response and repeatability of design between 2 similar doses	Comparison of response to be assessed until 7 days post-dose
Assess agouti related protein levels in this population	Day of dosing

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Leeds, West Yorkshire, United Kingdom