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NCT Number: NCT00644631

A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate

To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The male patient must have had a documented clinical diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of less than or equal to 21
  • a stable female partner at least 21 years of age for at least 6 months prior to screening
  • the couple must have been married or living together at the time of screening.
  • The female partner must have answered "no intercourse," "sometimes," "a few times" or "almost never" on Question 3 of the Female Partner of ED Subject Questionnaire (FePEDS-Q)

Exclusion criteria

  • The male patient must not have had resting sitting and/or standing hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg), or significant cardiovascular disease in the last 3 months, including cardiac failure, myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias.
  • Female partners must not have had significant dyspareunia or lifelong significant sexual dysfunction based on female partner's medical and sexual history at screening.

Treatment and study plan

Sildenafil

Drug

sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.

Placebo

Drug

placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks

Primary outcomes

  1. Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.

    Time frame: Week 12

Secondary outcomes

  1. International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients

    Time frame: Week 8 and Week 12

  2. Self-Esteem and Relationship Questionnaire (SEAR) in ED patients

    Time frame: Week 12

  3. ED Subject Event Log in ED patients

    Time frame: Week 12

  4. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients

    Time frame: Week 12

  5. Dyadic Adjustment Scale (DAS) in ED patients

    Time frame: Week 8 and Week 12

  6. American Urological Association (AUA) Symptom Index in ED patients

    Time frame: Week 12

  7. Global Efficacy Assessment Questions (GEQ) in ED patients

    Time frame: Week 12

  8. Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners

    Time frame: Week 8 and Week 12

  9. Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners

    Time frame: Week 12

  10. Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners

    Time frame: Week 12

  11. Partner EDITS in female partners

    Time frame: Week 12

  12. Female Partner Treatment Continuation Question in female partners

    Time frame: Week 12

  13. Dyadic Adjustment Scale (DAS) in female partners

    Time frame: Week 8 and Week 12

  14. Beck Depression Inventory (BDI-II) in female partners

    Time frame: Week 12

  15. Female Partner Event Log in female partners

    Time frame: Week 12

  16. AUA Symptom Index in female partners

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate) In The United States

Important dates

Study start
2003
Study completion
2004
First posted
Mar 27, 2008
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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