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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Sexual Dysfunction, Physiological

Treatments: Drug: Placebo; Drug: CP-866,087

Study type: Interventional

Funder types: Industry

Identifiers

NCT00482664

A5051017

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups, including a placebo group

1 mg

Experimental group

Treatment:

Drug: CP-866,087

Drug: CP-866,087

Drug: CP-866,087

10 mg

Experimental group

Treatment:

Drug: CP-866,087

Drug: CP-866,087

Drug: CP-866,087

3 mg

Experimental group

Treatment:

Drug: CP-866,087

Drug: CP-866,087

Drug: CP-866,087

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo