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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

May 24, 2007
May 28, 2007
April 8, 2009
June 2007
February 2008   (Final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00479570 on ClinicalTrials.gov Archive Site
  • Assess effect of single doses on medium term (1 week) sexual arousal and interest. [ Time Frame: 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 ]
  • If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period. [ Time Frame: Day of dosing ]
  • Assess PK , safety and toleration on day 1 of each study period. [ Time Frame: Day of dosing ]
  • Assess effect of single doses on medium term (1 week) sexual arousal and interest.
  • Assess variability of response and repeatability of design between 2 similar doses. Assess PK , safety and toleration on day 1 of each study period.
  • If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period
Not Provided
Not Provided
 
Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Female Sexual Dysfunction
  • Drug: PF-00446687
    Single 200mg dose
  • Drug: Placebo
  • Experimental: Study period 1, 2 or 3
    Intervention: Drug: PF-00446687
  • Placebo Comparator: Placebo Study period 1, 2 or 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
24
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
45 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Norway,   Sweden
 
 
NCT00479570
A8361015
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP