Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512707
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2007-08-07
Brief Title:
Effect of Testosterone in Men With Erectile Dysfunction
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Androgen Modulation of Response to Selective Phosphodiesterase Inhibitors in Erectile Dysfunction
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TED
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
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 ngdL measured by liquid chromatography tandem mass spectrometry LC-MSMS 15 andor free testosterone level measured by equilibrium dialysis below 50 pgml 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The initial assessment will be made prior to treatment with sildenafil citrate ie in subjects who are naïve to or withdrawn from PDE5 inhibitors andor testosterone Participants will then be allotted three sildenafil citrate tablets per week 12 pills per month but will not use more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 eg 500-1000 ngdL In order to assure that serum testosterone levels are in the target range 500-1000 ngdL testosterone dose will be adjusted by an unblinded individual two to three weeks after initiation of testosteroneplacebo treatment based on the measurement of serum testosterone levels If the average testosterone level is less than 500 ngdL the daily dose will be increased to 15g of active gel If the average testosterone is greater than 1000 ngdL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD047722-01A1 | NIH | None | httpsreporternihgovquickSearchR01HD047722-01A1 |