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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00479570

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 II

MedlinePlus related topics: Menopause

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
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).

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
Study period 1, 2 or 3: Experimental	Drug: PF-00446687 Single 200mg dose
Placebo Study period 1, 2 or 3: Placebo Comparator	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

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8361015
Study First Received:	May 24, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00479570
Health Authority:	N: Medicines Agency; Directorate for Health+Social affairs; S: Medical Prod Agency; Dk: Medc Agency

Study placed in the following topic categories:

Menopause

ClinicalTrials.gov processed this record on January 16, 2009