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

Completed · Phase 4

Conditions studied: Sexual Dysfunction, Depression

In brief

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.

Key facts

Study ID

NCT00375297

Run by

University of New Mexico

People needed

100

Starts

2001-01-01

Expected to finish

2005-06-01

Last updated by the study team

2006-09-12

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Primary or prior diagnosis of a sexual disorder (other than the side effect of the antidepressant drug or symptom of major depression).
• Vaginal, clitoral, or other sexual organ anatomical deformities.
• Post-hysterectomy with or without oophorectomy without at least six months of postoperative normal sexual function preceding depression and antidepressant treatment.
• Any uncontrolled psychiatric disorder.
• Alcohol or substance abuse or dependence within past twelve months.
• Using or likely to use any nitrate or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational, or aerosol).
• Hamilton Depression and/or Anxiety Scale score [either] > 10.
• Blood pressure outside 90/50 or 170/100.
• Use of investigational drugs within prior 3 months or during study.
• Current use of other drugs for antidepressant induced sexual dysfunction.
• Hormone replacement therapy unless patient has been on stable dose of hormone therapy for at least 3 months prior to the antidepressant treatment and had no sexual dysfunction while on the same hormone therapy regimen, and there is no change in the hormone replacement therapy during the study.
• Pregnancy, lactating, or planning to become pregnant during the study.
• Child bearing potential subjects unwilling and/or not prepared and/or who are judged unreliable to use an acceptable and verifiable form of contraception during the study (these include IUD, double barrier or hormonal methods of birth control).
• Any clinically significant abnormality of the screening physical examination or safety laboratory test results.
• Subjects whose sexual partners are suffering from and/or receiving treatment for sexual dysfunction.
• eceiving psychosexual or other therapy for sexual dysfunction and not willing to discontinue that treatment at screening.
• Amenorrhea for greater than 1 year.
• Subjects whose sexual dysfunction is considered to be situational, i.e. limited to certain types of situations, stimulation, or partners.
• Subjects not attempting some form of regular sexual activity at least twice monthly and at least once weekly during study visit intervals for the duration of the entire study.
• Changes in antidepressant agent and or dose of prescribed antidepressant agent.

Where it is running

• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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