NCT00375297

Study of Sildenafil for Treatment of SSRI-Antidepressant Sexual Dysfunction in Women

Randomized Double Blind Placebo Controlled Study of Sildenafil for Treatment of Serotonergic Reuptake Inhibitor Associated Sexual Dysfunction in Women With Major Depression Treated to Remission

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual dysfunction (SRI-AASD) following the same protocol which previously established efficacy in men with SRI-AASD.

Detailed description

This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual dysfunction (SRI-AASD) following the same protocol which previously established efficacy in men with SRI-AASD. Women (n=100) with MDD-remission and SRI-AASD were randomized to receive sildenafil (50-100mg) or placebo for 8 weeks, followed by 8-weeks open-label extension. Sexual function was assessed using the Clinical Global Impression-Sexual Function (CGI-SF), with positive response defined as a score \<3, and UNM-SFI, ASEX, SFQ-FSD sexual function questionnaires. Depression was monitored using the HAM-D17. Hypothalamic-pituitary-adrenal-gonadal hormones were measured at baseline and DB-endpoint.

Conditions

• Sexual Dysfunction
• Depression

Interventions

Type	Name	Description
DRUG	sildenafil

Timeline

• Start date: 2001-01-01
• Completion: 2005-06-01
• First posted: 2006-09-12
• Last updated: 2006-09-12

Locations

1 site across 1 country: United States