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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00479570
First received: May 24, 2007
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479570

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on October 19, 2014