The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00482664
• Collaborator: (none)
• Enrollment: 84
• Locations: 12
• Arms: 4
• Duration (Months): 15
• Patients Per Site: 7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been shown in animal models to restore sexual function.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction, Physiological	Drug: CP-866,087; Drug: CP-866,087; Drug: CP-866,087; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2a Multi-Centre, Double Blind, Placebo Controlled Cross-Over Trial To Investigate The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women Diagnosed With Female Sexual Arousal Disorder (FSAD).
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 mg	Drug: CP-866,087; Tablets for oral administration
Experimental: 10 mg	Drug: CP-866,087; Tablets for oral administration
Experimental: 3 mg	Drug: CP-866,087; Tablets for oral administration
Placebo Comparator: Placebo	Drug: Placebo; Tablets for oral administration

Outcome Measures

Primary Outcome Measures

1. Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. [6 weeks]

2. Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. [6 weeks]

Secondary Outcome Measures

1. Exit interview at end of study. Meaningful Benefit Question at end of study. [End of study]

2. Measure of Female Sexual Distress questionnaire after 6 weeks of treatment. [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• healthy pre-menopausal women

• primary female sexual arousal disorder causing distress

• on stable use of oral contraceptives

Exclusion Criteria:

• any other significant disease causing Female Sexual Dysfunction including psychiatric disease

• subjects on drugs known to cause Female Sexual Dysfunction

• subjects who have given birth in the last 12 months or who are planning to become pregnant during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Dulwich	South Australia	Australia	5065
2	Pfizer Investigational Site	Nedlands	Western Australia	Australia	6009
3	Pfizer Investigational Site	Aarhus C		Denmark	8000
4	Pfizer Investigational Site	Kobenhavn OE		Denmark	2100
5	Pfizer Investigational Site	Odense C		Denmark	5000
6	Pfizer Investigational Site	Oslo		Norway	0277
7	Pfizer Investigational Site	Westville	Kwa-Zulu Natal	South Africa	3629
8	Pfizer Investigational Site	Pretoria		South Africa	0132
9	Pfizer Investigational Site	Lund		Sweden	221 85
10	Pfizer Investigational Site	Skovde		Sweden	541 30
11	Pfizer Investigational Site	Stockholm		Sweden	141 86
12	Pfizer Investigational Site	Stockholm		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: NCT00482664
• Other Study ID Numbers: A5051017
• First Posted: Jun 5, 2007
• Last Update Posted: Nov 1, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Study Results

No Results Posted as of Nov 1, 2010