Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163566
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2005-09-09
Brief Title:
Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80
Sponsor:
ASCEND Therapeutics
Organization:
ASCEND Therapeutics
Study Overview
Official Title:
A Phase II Placebo-Controlled Double-Blind Dose-Ranging 35mgDay or 70 mgDay Randomized Study of Cutaneous Dihydrotestosterone DHT-Gel 07 Hydroalcoholic Gel in Older Hypogonadal Males Ages 55-80 Years Effect on Body Composition Libido and Physical and Sexual Functioning
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
The purpose of this study is to evaluate whether DHT-Gel when applied daily to the skin can relieve the symptoms of low testosterone in men aged 55-80 These symptoms include reduced muscle strength increase fat mass low libido feeling blue or moody
Detailed Description:
Background - In the context of hypogonadism androgen supplementation is clearly beneficial particularly in younger males The benefits of therapy in men with milder degrees of hypogonadism and elderly males with testosterone deficiency are less clear-cut Several options are available for androgen replacement in adult men Oral testosterone intramuscular injections subcutaneous implants and transdermal therapy have all been used Each mode of delivery has advantages and drawbacks Several alkylated derivatives of T are available for oral or sublingual use including methyl testosterone and fluoxymesterone However they are not recommended for use as replacement therapy because of their associated adverse effects
Study Design - This is a multi-center double-blind placebo-controlled parallel group randomized study of DHT-Gel versus placebo gel in male subjects ages 55-80 years inclusive with low serum testosterone and symptoms compatible with the clinical diagnosis of hypogonadism Total enrollment for this study will be approximately 120 subjects 40 subjects for each treatment group Subjects will be treated with 35 mgday DHT 70 mgday DHT or placebo gel for 6 months All subjects will apply the gel once daily Up to 9 months of study participation including up to 2 months of screening and a 1-month follow-up period will be required by the protocol
The primary efficacy endpoint in this study is change in body composition as determined by DEXA scan Secondary endpoints in this study include change in sexual libido and overall function and mood and normalization of serum androgen levels A subset of sites will perform strength assessments which will include handgrip dynamometry and upper and lower body strength tests
Study Design - This is a multi-center double-blind placebo-controlled parallel group randomized study of DHT-Gel versus placebo gel in male subjects ages 55-80 years inclusive with low serum testosterone and symptoms compatible with the clinical diagnosis of hypogonadism Total enrollment for this study will be approximately 120 subjects 40 subjects for each treatment group Subjects will be treated with 35 mgday DHT 70 mgday DHT or placebo gel for 6 months All subjects will apply the gel once daily Up to 9 months of study participation including up to 2 months of screening and a 1-month follow-up period will be required by the protocol
The primary efficacy endpoint in this study is change in body composition as determined by DEXA scan Secondary endpoints in this study include change in sexual libido and overall function and mood and normalization of serum androgen levels A subset of sites will perform strength assessments which will include handgrip dynamometry and upper and lower body strength tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None