Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.

January 29, 2019 updated by: Pfizer

Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Kobenhavn OE, Denmark, 2100
        • Pfizer Investigational Site
  • Norway
      • Oslo, Norway
        • Pfizer Investigational Site
  • Sweden
      • Danderyd, Sweden, S-182 88
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who have evidence of Female Sexual Arousal Disorder.
  • Women who experience personal distress due to Female Sexual Dysfunction.
  • Post menopausal women aged between 45 and 65 years.

Exclusion Criteria:

  • Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
  • Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
  • Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study period 1, 2 or 3
Drug: PF-00446687
Single 200mg dose
Placebo Comparator: Placebo Study period 1, 2 or 3
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: From day of dosing until 7 days post-dose
From day of dosing until 7 days post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess effect of single doses on medium term (1 week) sexual arousal and interest.
Time Frame: Until 7 days post-dose
Until 7 days post-dose
Assess variability of response and repeatability of design between 2 similar doses.
Time Frame: Comparison of response to be assessed until 7 days post dose
Comparison of response to be assessed until 7 days post dose
If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.
Time Frame: Day of dosing
Day of dosing
Assess PK , safety and toleration on day 1 of each study period.
Time Frame: Day of dosing
Day of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 25, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • A8361015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Female Sexual Dysfunction

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe