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PF-00446687

Phase 2

Erectile Dysfunction | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Jan 31, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

PF-00446687 · 2 trials · 2 indications

Phase 2 2
NCT00862888Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile DysfunctionErectile Dysfunction
COMPLETED39 Analytics
NCT00479570Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.Female Sexual Dysfunction
COMPLETED23 Analytics
PHASE2COMPLETED
Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction
Erectile DysfunctionUnlock trial analytics
PHASE2COMPLETED
Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.
Female Sexual DysfunctionUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1; Study Period 1, 2, 3 or 4PLACEBO_COMPARATORCohort 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 4PLACEBO_COMPARATORCohort 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 3EXPERIMENTAL -
Placebo Study period 1, 2 or 3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-00446687DRUGSingle 200mg dose as an oral solution
PlaceboDRUGPlacebo for oral solution
SildenafilDRUGSingle oral dose 100 mg tablet
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites3

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...

Countries:NorwayUnited KingdomDenmarkSweden
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Frequently asked questions about PF-00446687

What is PF-00446687 used for?

PF-00446687 is an investigational small molecule being developed by Pfizer for the treatment of Erectile Dysfunction and Female Sexual Dysfunction. It is in Phase 2 clinical development, meaning it is not yet approved and is still being studied for safety and efficacy in these conditions.

Who makes PF-00446687?

PF-00446687 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for Erectile Dysfunction and Female Sexual Dysfunction.

What phase is PF-00446687 in?

PF-00446687 is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Two Phase 2 trials have been completed, one in post-menopausal women with Female Sexual Dysfunction and one in males with Erectile Dysfunction.

What clinical trials is PF-00446687 in?

PF-00446687 has completed two Phase 2 clinical trials. NCT00479570 studied the drug in post-menopausal women with Female Sexual Dysfunction, enrolling 23 participants in Denmark, Norway, and Sweden. NCT00862888 studied the drug in males with Erectile Dysfunction, enrolling 39 participants in Norway and the United Kingdom.

How does PF-00446687 work?

PF-00446687 is a small molecule designed to treat sexual dysfunction. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not publicly detailed. The drug is being studied for its effects on Erectile Dysfunction and Female Sexual Dysfunction.