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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: May 24, 2007
Last updated: April 7, 2009
Last verified: April 2009

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.

Condition Intervention Phase
Female Sexual Dysfunction
Drug: PF-00446687
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess effect of single doses on medium term (1 week) sexual arousal and interest. [ Time Frame: Until 7 days post-dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period. [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]
  • Assess PK , safety and toleration on day 1 of each study period. [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study period 1, 2 or 3 Drug: PF-00446687
Single 200mg dose
Placebo Comparator: Placebo Study period 1, 2 or 3 Drug: Placebo


Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00479570

Pfizer Investigational Site
Kobenhavn OE, Denmark, 2100
Pfizer Investigational Site
Oslo, Norway
Pfizer Investigational Site
Danderyd, Sweden, S-182 88
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00479570     History of Changes
Other Study ID Numbers: A8361015
Study First Received: May 24, 2007
Last Updated: April 7, 2009
Health Authority: N: Medicines Agency; Directorate for Health+Social affairs; S: Medical Prod Agency; Dk: Medc Agency

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders processed this record on April 17, 2014