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Trial record 1 of 1 for:    NCT00479570
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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 : January 31, 2019
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 24, 2007
First Posted Date  ICMJE May 28, 2007
Last Update Posted Date January 31, 2019
Study Start Date  ICMJE June 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2007)
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.
Change History Complete list of historical versions of study NCT00479570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2007)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.
Official Title  ICMJE 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).
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Female Sexual Dysfunction
Intervention  ICMJE
  • Drug: PF-00446687
    Single 200mg dose
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Study period 1, 2 or 3
    Intervention: Drug: PF-00446687
  • Placebo Comparator: Placebo Study period 1, 2 or 3
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2008)
23
Original Enrollment  ICMJE
 (submitted: May 25, 2007)
24
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479570
Other Study ID Numbers  ICMJE A8361015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019

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