Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder

Viatris

Status and phase: Completed; Phase 2

Conditions: Female Sexual Arousal Disorder

Treatments: Drug: Placebo; Drug: Sildenafil 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640458

A1481174

Details and patient eligibility

About

The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-menopausal women aged 18-45 with a primary diagnosis of Female Sexual Arousal Disorder for at least 6 months prior to entering the study. The FSAD could have been associated with female orgasmic disorder (FOD) and/or superficial or introital dyspareunia.

Exclusion criteria

• Subjects with hypoactive sexual desire disorder.
• Subjects not using an acceptable mean of contraception for the duration of the study.
• Subjects who were prescribed and/or taking medication which were contraindicated or cautioned with concomitant intake of sildenafil.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Study Period 1 or 2

Treatment:

Drug: Placebo

Experimental

Experimental group

Description:

Study Period 1 or 2

Treatment:

Drug: Sildenafil 100 mg