Study of Sildenafil for Treatment of SSRI-Antidepressant Sexual Dysfunction in Women
NCT00375297
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
S Subjects will be females only, ages 18 to 50 years.
- Subjects have been taking an SSRI, venlafaxine, nefazodone, or tri/hetero cyclic antidepressant for treatment of depression for at least 8 weeks, are currently at a stable dose of the antidepressant for at least 4 weeks, and have been consistently experiencing arousal dysfunction [inability to attain or maintain until completion of sexual activity an adequate lubrication swelling response of sexual excitement] or orgasmic dysfunction [delayed orgasm/anorgasmia following a normal sexual excitement phase] that interferes with sexual functioning for at least 4 weeks.
- Subjects must currently be euthymic (HAM-D<10) and without significant anxiety symptoms (HAM-A<10).
- Subjects must have had no sexual dysfunction prior to taking an antidepressant and there must be a clear temporal relationship of the sexual dysfunction to the antidepressant treatment. [Note - sexual dysfunction occurring as a symptom of the depressive disorder for which AD treatment was initiated is not considered to be a pre-existing condition in this definition].
- Subjects must meet at least one of the following criteria:
1. Inability to have an orgasm (anorgasmia), according to patient opinion.
2. Clinically significant orgasm delay with masturbation or intercourse that according to patient opinion:
1. represents a meaningful delay compared with the subject's usual time to achieve orgasm in response to sexual stimulation prior to antidepressant medication and
2. interferes with subject's sexual function.
3. Inability to attain or maintain until completion of sexual activity an adequate lubrication swelling response of sexual excitement that according to patient opinion interferes with subject's sexual function compared to prior to antidepressant medication.
- Subjects must experience at least one of the above criterion items (#1-3) with distress and or disability.
- Subjects must be having or had been having some form of regular sexual activity (i.e., masturbation, oral sex, intercourse) at least twice monthly prior to the antidepressant treatment and are willing to continue efforts at sexual activity at least once weekly for the duration of the study.
- Subjects must be in good general physical health.
- Subjects must have given informed consent to participate in the study.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Albuquerque, New Mexico
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study of Sildenafil for Treatment of SSRI-Antidepressant Sexual Dysfunction in Women | |||
Official Title ICMJE | 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 | |||
Brief 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: sildenafil | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 100 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | June 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:S Subjects will be females only, ages 18 to 50 years.
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00375297 | |||
Other Study ID Numbers ICMJE | 99321 Acc# 4-37011 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | University of New Mexico | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | University of New Mexico | |||
Verification Date | September 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |