Erectile DysfunctionPhase 4TEDNCT00512707
Effect of Testosterone in Men With Erectile Dysfunction
A Phase 4 study testing Sildenafil citrate (open label) and Testosterone gel in people with Erectile Dysfunction and Testosterone Deficiency, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Testosterone Deficiency, Diabetes
- What is being tested?
- Sildenafil citrate (open label) and Testosterone gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Men who are taking medications for erectile dysfunction, including sildenafil, must stop using these medications for at least 4 weeks before starting Visit 2.
- DSM-IV criteria for an Axis I psychiatric disorder within the past year, including depression; use of psychotropic medication for at least six months, or dementia is also an exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Androgen Modulation of Response to Selective Phosphodiesterase Inhibitors in Erectile Dysfunction
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.
Read the detailed description
This is a double-blind, placebo-controlled, parallel-group, randomized clinical trial in men, 40-70 years of age, who present with mild to moderate erectile dysfunction and have androgen deficiency defined as serum total testosterone level below 300 ng/dL, measured by liquid chromatography tandem mass spectrometry, LC-MS/MS (15) and/or free testosterone level (measured by equilibrium dialysis) below 50 pg/ml. Sexual function assessments will include validated erectile function questionnaires (IIEF), sexual activity diaries, sexual desire, partner interaction and intimacy, affects balance scale, mood, ED-related quality of life, and penile rigidity in response to a visual erotic stimulus. The initial assessment will be made prior to treatment with sildenafil citrate, i.e., in subjects who are naïve to or withdrawn from PDE5 inhibitors and/or testosterone. Participants will then be allotted three sildenafil citrate tablets per week (12 pills per month), but will not use more than one tablet within any 24-hour period. During the Sildenafil-Dose Optimization period, subjects naïve to sildenafil citrate will start with a 50 mg dose. Those who have used sildenafil citrate in the past will take the same dose that was found to be efficacious for them. After three weeks, the dose of sildenafil citrate will be increased to 100-mg in non-responders. For those who cannot tolerate the 50-mg dose, a dose of 25 mg will be given. After three weeks on the optimized dose of sildenafil citrate, subjects will undergo a second evaluation of sexual function. They will then be randomly assigned to receive this optimized dose of sildenafil citrate with either placebo gel (15 g per day) or active testosterone gel (10 g active gel + 5 g placebo gel per day). The daily dose of active testosterone gel was selected to increase average serum into the upper-half of the normal range for healthy, young men (e.g., 500-1000 ng/dL). In order to assure that serum testosterone levels are in the target range (500-1000 ng/dL), testosterone dose will be adjusted by an unblinded individual two to three weeks after initiation of testosterone/placebo treatment, based on the measurement of serum testosterone levels. If the average testosterone level is less than 500 ng/dL, the daily dose will be increased to 15g of active gel. If the average testosterone is greater than 1,000 ng/dL, the daily dose will be decreased to 5 g of active gel (and 10 g of placebo gel). This dose adjustment will take effect at week 4 (day 28) of treatment. Subjects will be treated for an additional 12-weeks with sildenafil citrate and the optimized dose of testosterone gel or placebo gel. Sexual function will be evaluated at the end of this treatment period.
- Conditions
- Erectile Dysfunction, Testosterone Deficiency, Diabetes
- Being tested
- Sildenafil citrate (open label), Testosterone gel, Placebo gel
- Keywords
- testosterone, erectile dysfunction, sildenafil
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrate (open label)Drug
Also called Viagra (Pfizer Inc.)
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.
Testosterone gelDrug
Also called Testim (Auxilium Pharmaceuticals, Inc.)
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.
Placebo gelOther
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..
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sildenafil citrate (open label); Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, week 8, week 11, week 14
Secondary outcomes (9)
Change From Baseline in Other Domains of 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 a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Measured: Week 0, week 8, week 11, week 14
Change From Baseline in Sexual Encounter Profile (SEP)
Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Minimum value is 0 with no maximum limit, wherein higher values representing better sexual encounter.
Measured: Week 0, week 8, week 14
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Higher percentage of Ejaculations or Satisfaction in successful sexual intercourse represents better sexual function.
Measured: Week 0, week 8, week 14
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
MSHQ, a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). A composite score is the sum of Ejaculation and Satisfaction domains, ranging from 7 to 65 (best), with higher score representing better sexual function and satisfaction.
Measured: Week 0, Week 8, Week 14
Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)
The Quality of Life for men with Erection Difficulties (QOL-MED) is a cross-cultural instrument to measure quality of life specific to male erection difficulties. The 18 items for this scale were generated from interviews with men with erection difficulties by TH Wagner in 1996. Higher QOL-MED scores reflect better quality of life. Scores were standardized to range of 0 to 100.
Measured: Week 0, Week 8, Week 14
Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
CAncer Rehabilitation Evaluation System-short form (CARES-SF) marital interaction scale consists of 6 items (range from 0 (best) to 4) and mean of these 6 questions was used to determine intimacy and partner interaction. Lower CARES-SF scores correspond with improved marital interaction.
Measured: Week 0, Week 8, Week 14
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Well-being and mood were assessed using the Psychological General Well-Being Index (PGWBI), a 22-item questionnaire that evaluated six dimensions of self-reported wellness: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). Higher scores in each dimension reflect increasing well-being. A global score (ranging from 0 (poor QoL) to 110 (good QoL)) was calculated as the sum of each domain score. The global score and those of its 6 dimensions were normalized to a 100% scale to facilitate comparison.
Measured: Week 0, Week 8, Week 14
Change From Baseline in Derogatis Affects Balance Scale (DABS)
The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Each domain was calculated as the sum of 5-items and could range from 0 to 20, wherein higher scores indicate greater affectivity.
Measured: Week 0, Week 8, Week 14
Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)
The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Positive Affects Ratio (PAR), ranging from 0 to 1, is the proportion of total scores (sum of all 8 domains) that is positive (sum of 4 positive domains). Higher PAR represents better affectivity.
Measured: Week 0, Week 8, Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startNov 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512707
- Sponsor's protocol ID
- H-25065
- Other IDs
- R01HD047722-01A1
- Acronym
- TED
- Status last verified
- May 2017
- First submitted
- 7 Aug 2007
- Last updated
- 29 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38224135Wilson 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.
PubMed 35790332Spitzer 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.
PubMed 24106072Spitzer 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.
PubMed 23494931Spitzer 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.
PubMed 23165659
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Modulation of Response to Selective Phosphodiesterase Inhibitors in Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00512707
- Acronym / sponsor ID
- TED / H-25065
- Conditions
- Erectile Dysfunction, Testosterone Deficiency, Diabetes
- Keywords
- testosterone, erectile dysfunction, sildenafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Posted 29 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a double-blind, placebo-controlled, parallel-group, randomized clinical trial in men, 40-70 years of age, who present with mild to moderate erectile dysfunction and have androgen deficiency defined as serum total testosterone level below 300 ng/dL, measured by liquid chromatography tandem mass spectrometry, LC-MS/MS (15) and/or free testosterone level (measured by equilibrium dialysis) below 50 pg/ml. Sexual function assessments will include validated erectile function questionnaires (IIEF), sexual activity diaries, sexual desire, partner interaction and intimacy, affects balance scale, mood, ED-related quality of life, and penile rigidity in response to a visual erotic stimulus. The initial assessment will be made prior to treatment with sildenafil citrate, i.e., in subjects who are naïve to or withdrawn from PDE5 inhibitors and/or testosterone. Participants will then be allotted three sildenafil citrate tablets per week (12 pills per month), but will not use more than one tablet within any 24-hour period. During the Sildenafil-Dose Optimization period, subjects naïve to sildenafil citrate will start with a 50 mg dose. Those who have used sildenafil citrate in the past will take the same dose that was found to be efficacious for them. After three weeks, the dose of sildenafil citrate will be increased to 100-mg in non-responders. For those who cannot tolerate the 50-mg dose, a dose of 25 mg will be given. After three weeks on the optimized dose of sildenafil citrate, subjects will undergo a second evaluation of sexual function. They will then be randomly assigned to receive this optimized dose of sildenafil citrate with either placebo gel (15 g per day) or active testosterone gel (10 g active gel + 5 g placebo gel per day). The daily dose of active testosterone gel was selected to increase average serum into the upper-half of the normal range for healthy, young men (e.g., 500-1000 ng/dL). In order to assure that serum testosterone levels are in the target range (500-1000 ng/dL), testosterone dose will be adjusted by an unblinded individual two to three weeks after initiation of testosterone/placebo treatment, based on the measurement of serum testosterone levels. If the average testosterone level is less than 500 ng/dL, the daily dose will be increased to 15g of active gel. If the average testosterone is greater than 1,000 ng/dL, the daily dose will be decreased to 5 g of active gel (and 10 g of placebo gel). This dose adjustment will take effect at week 4 (day 28) of treatment. Subjects will be treated for an additional 12-weeks with sildenafil citrate and the optimized dose of testosterone gel or placebo gel. Sexual function will be evaluated at the end of this treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Testosterone Gel | Experimental | Drug: Sildenafil citrate (open label), Drug: Testosterone gelActive 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. |
| Placebo Gel | Placebo comparator | Drug: Sildenafil citrate (open label), Other: Placebo gelPlacebo 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil citrate (open label)Also: Viagra (Pfizer Inc.)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 | Active Testosterone Gel, Placebo Gel |
| Testosterone gelAlso: Testim (Auxilium Pharmaceuticals, Inc.)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. | Drug | Active Testosterone Gel |
| Placebo gel3 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.. | Other | Placebo Gel |
Primary outcome
Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)
Time frame: Week 0, week 8, week 11, week 14
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.
9 secondary outcomes
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Time frame: Week 0, week 8, week 11, week 14
Change From Baseline in Sexual Encounter Profile (SEP)
Time frame: Week 0, week 8, week 14
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Time frame: Week 0, week 8, week 14
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Time frame: Week 0, Week 8, Week 14
Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)
Time frame: Week 0, Week 8, Week 14
Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
Time frame: Week 0, Week 8, Week 14
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Time frame: Week 0, Week 8, Week 14
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Time frame: Week 0, Week 8, Week 14
Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)
Time frame: Week 0, Week 8, Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38224135Lee 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.
- Derived from this study: PubMed 35790332Wilson 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.
- Derived from this study: PubMed 24106072Spitzer 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.
- Derived from this study: PubMed 23494931Spitzer 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.
- Derived from this study: PubMed 23165659Spitzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil citrate (open label) and Testosterone gel in people with Erectile Dysfunction and Testosterone Deficiency, run by Boston University 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 4 inclusion and 17 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 29 Jun 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) (time frame: Week 0, week 8, week 11, week 14). 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 NCT00512707, which also lists 5 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 29 Jun 2017.