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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00479570
• Collaborator: (none)
• Enrollment: 23
• Locations: 3
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 7.7
• Patients Per Site Per Month: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jun 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

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

Outcome Measures

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. [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. [Until 7 days post-dose]

2. Assess variability of response and repeatability of design between 2 similar doses. [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. [Day of dosing]

4. Assess PK , safety and toleration on day 1 of each study period. [Day of dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Kobenhavn OE		Denmark	2100
2	Pfizer Investigational Site	Oslo		Norway
3	Pfizer Investigational Site	Danderyd		Sweden	S-182 88

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00479570
• Other Study ID Numbers: A8361015
• First Posted: May 28, 2007
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 2019

Study Results

No Results Posted as of Jan 31, 2019