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

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ClinicalTrials.gov Identifier: NCT00479570
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : April 8, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Female Sexual Dysfunction Drug: PF-00446687 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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).
Study Start Date : June 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess effect of single doses on medium term (1 week) sexual arousal and interest. [ Time Frame: Until 7 days post-dose ]
  2. 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 ]
  3. If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period. [ Time Frame: Day of dosing ]
  4. Assess PK , safety and toleration on day 1 of each study period. [ Time Frame: Day of dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00479570     History of Changes
Other Study ID Numbers: A8361015
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009