AzTrials
AzTrials

Sexual DysfunctionPhase 4NCT00375297

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

A Phase 4 study testing sildenafil in people with Sexual Dysfunction and Depression, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Sexual Dysfunction, Depression
What is being tested?
sildenafil
How many people
100 participants
Where
1 siteUnited States
Study dates
Jan 2001to Jun 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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).
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
sildenafil
Keywords
antidepressants, sexual dysfunction, women, sildenafil, PDE5 inhibitors, serotonin reuptake inhibitor antidepressants
Medical subject headings
Sexual Dysfunction, Physiological, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical global improvement in sexual function

Secondary outcomes (3)

  1. UNM-Sexual function inventory

  2. Arizona Sexual Function Scale

  3. Female sexual function questionnaire

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2006 (estimated)
  2. Study startJan 2001
  3. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00375297
Sponsor's protocol ID
99321
Other IDs
Acc# 4-37011
Status last verified
Sep 2006
First submitted
11 Sep 2005
Last updated
12 Sep 2006
Results posted
No

Publications

  • Nurnberg HG, Hensley PL, Gelenberg AJ, Fava M, Lauriello J, Paine S. Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial. JAMA. 2003 Jan 1;289(1):56-64. doi: 10.1001/jama.289.1.56.

    PubMed 12503977

  • Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S. Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. JAMA. 2008 Jul 23;300(4):395-404. doi: 10.1001/jama.300.4.395.

    PubMed 18647982

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sildenafil in people with Sexual Dysfunction and Depression, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical global improvement in sexual function. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00375297, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2006.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in