Effect of Testosterone in Men With Erectile Dysfunction

NCT00512707 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: H-25065R01HD047722-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this placebo-controlled study is to determine if testosterone replacement therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R) treatment in men who have erectile dysfunction (ED) and low testosterone levels.

Conditions

Erectile Dysfunction; Testosterone Deficiency; Diabetes

Keywords

testosterone; erectile dysfunction; sildenafil

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)

  IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function.

  Week 0, week 8, week 11, week 14

Secondary Outcomes (9)

• Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)

  Week 0, week 8, week 11, week 14

• Change From Baseline in Sexual Encounter Profile (SEP)

  Week 0, week 8, week 14

• Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)

  Week 0, week 8, week 14

• Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)

  Week 0, Week 8, Week 14

• Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)

  Week 0, Week 8, Week 14

Other Outcomes (3)

• Change From Baseline in Total Testosterone

  Week 0, Week 14

• Change From Baseline in Free Testosterone

  Week 0, Week 14

• Change From Baseline in Sex Hormone Binding Globulin (SHBG)

  Week 0, Week 14

Study Arms (2)

Active Testosterone Gel

EXPERIMENTAL

Active Testosterone Gel and on demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.

Drug: Sildenafil citrate (open label); Drug: Testosterone gel

Placebo Gel

PLACEBO COMPARATOR

Placebo Gel and on demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.

Drug: Sildenafil citrate (open label); Other: Placebo gel

Interventions

Sildenafil citrate (open label) DRUG

On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.

Also known as: Viagra (Pfizer Inc.)

Active Testosterone Gel; Placebo Gel

Testosterone gel DRUG

Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.

Also known as: Testim (Auxilium Pharmaceuticals, Inc.)

Active Testosterone Gel

Placebo gel OTHER

3 tubes of placebo gel equivalent to the amount of the testosterone gel will be applied during the placebo-controlled testosterone gel intervention for 16 weeks..

Placebo Gel

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men, 40-70 years of age, in a stable relationship, with mild to moderate erectile dysfunction for at least 6 months; defined as an IIEF-EF domain score between 11 and 25 (mild to moderate ED)
• Neutral or extremely dissatisfied with one's sex life
• Presence of androgen deficiency defined as serum total testosterone level less than 300 ng/dL (measured by LC-MS/MS) and/or free testosterone level (measured by equilibrium dialysis) less than 50 pg/ml.
• Able to understand the nature of the study and provide written, informed consent

You may not qualify if:

• Contraindication for use of testosterone, e.g., history of prostate or breast cancer
• benign prostatic hyperplasia with AUA/IPSS symptom scores of 21 or greater
• erythrocytosis (hematocrit \>50% at baseline)
• untreated, severe sleep apnea
• serum PSA levels \>4 ug/L will be excluded unless they have had a urologic evaluation in the past three months to exclude prostate cancer.
• Contraindication for use of sildenafil, e.g., symptomatic coronary artery disease taking long-acting or short-acting nitrate drugs on a regular basis.
• Symptomatic postural hypotension
• Congestive heart failure with class III or IV symptoms
• History of myocardial infarction or stroke within the past six months
• Primary diagnosis of another sexual disorder such as premature ejaculation
• AST, ALT, alkaline phosphatase elevation greater than three times the upper limit of normal, creatinine greater than 2 mg/dL.
• Currently taking testosterone or oral androgen precursors; unless willing to discontinue their use for 4 weeks (oral precursors or transdermal testosterone patch or gel) or 6 weeks (if injectable testosterone) before the initial screen visit.
• Currently taking medications that affect androgen metabolism, action, or clearance (dilantin, phenobarbital, aldactone, flutamide, finasteride).
• Uncontrolled diabetes mellitus or diabetes mellitus, e.g., if their baseline hemoglobin A1C is less than 8.5%.
• Structural abnormalities of the penis, including Peyronie's disease, will be excluded.

Sponsors & Collaborators

• Boston University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (5)

• Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2.

  PMID: 38224135 DERIVED

• Wilson E, Gannon H, Chimhini G, Fitzgerald F, Khan N, Lorencatto F, Kesler E, Nkhoma D, Chiyaka T, Haghparast-Bidgoli H, Lakhanpaul M, Cortina Borja M, Stevenson AG, Crehan C, Sassoon Y, Hull-Bailey T, Curtis K, Chiume M, Chimhuya S, Heys M. Protocol for an intervention development and pilot implementation evaluation study of an e-health solution to improve newborn care quality and survival in two low-resource settings, Malawi and Zimbabwe: Neotree. BMJ Open. 2022 Jul 5;12(7):e056605. doi: 10.1136/bmjopen-2021-056605.

  PMID: 35790332 DERIVED

• Spitzer M, Bhasin S, Travison TG, Davda MN, Stroh H, Basaria S. Sildenafil increases serum testosterone levels by a direct action on the testes. Andrology. 2013 Nov;1(6):913-8. doi: 10.1111/j.2047-2927.2013.00131.x. Epub 2013 Sep 18.

  PMID: 24106072 DERIVED

• Spitzer M, Basaria S, Travison TG, Davda MN, DeRogatis L, Bhasin S. The effect of testosterone on mood and well-being in men with erectile dysfunction in a randomized, placebo-controlled trial. Andrology. 2013 May;1(3):475-82. doi: 10.1111/j.2047-2927.2013.00075.x. Epub 2013 Mar 15.

  PMID: 23494931 DERIVED

• Spitzer M, Basaria S, Travison TG, Davda MN, Paley A, Cohen B, Mazer NA, Knapp PE, Hanka S, Lakshman KM, Ulloor J, Zhang A, Orwoll K, Eder R, Collins L, Mohammed N, Rosen RC, DeRogatis L, Bhasin S. Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a parallel, randomized trial. Ann Intern Med. 2012 Nov 20;157(10):681-91. doi: 10.7326/0003-4819-157-10-201211200-00004.

  PMID: 23165659 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus

Interventions

Sildenafil Citrate; Testosterone

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Shalender Bhasin
• Organization: Brigham and Women's Hospital

sbhasin@partners.org

617-525-9150

Study Officials

• Shalender Bhasin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: November 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)