Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT04545450
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2020-08-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen
Sponsor:
Unita Complessa di Ostetricia e Ginecologia
Organization:
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Pilot Trial on the Effects of Testosterone Undecanoate Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolic Profile in Transmen
Status:
COMPLETED
Status Verified Date:
2020-09
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:
DUTMUSCLE-20
Brief Summary:
To compare the effects on body composition and muscle strengthof 54-weeks treatment with of testosterone undecanoate combined with placebo or with the 5a-reductase inhibitor dutasteride
Detailed Description:
Transmen who have undergone gender-affirming surgery require long-lasting treatments with androgens to maintain male phenotypic characteristics and to preserve their health. In this population the effects on muscle and the relative role of testosterone and its metabolite dihydrotestosterone (DHT) on the skeletal muscle are still largely unknown.
In this pilot study, we evaluated the effects of testosterone and DHT on muscle strength, body composition, metabolism. Also cutaneous androgenic effects such as acne and androgenetic alopecia were evaluated.
DESIGN
For this purpose, in this randomized, double-blind placebo-controlled pilot trial we treated variectomized transmen for 54 weeks with:
* Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + a daily oral placebo pill (TU+PL)
* TU 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day (TU+DUT).
Prospective, phase III, randomized study design was used.
Subjects were seen every 12 weeks for safety monitoring that included evaluation of hematocrit, transaminases, alkaline phosphatases and bilirubin, creatinine, urea and serum electrolyte as potassium and sodium.
Baseline and week-54 evaluations included the following measurements:
blood drawings for measurements of: hormonal profile (serum testosterone, estradiol, luteinizing hormone and follicle-stimulating hormone, prolactin, sex hormone binding globulin, and thyroid stimulating hormone), haematocrit (Ht) and haemoglobin (Hb), glucidic and lipidic profile (fasting glucose, fasting insulin, total cholesterol, high- and low-density lipoproteins, and triglycerides), hepatic function (aspartate and alanine aminotransferases) and bone related markers (osteocalcin, parathyroid hormone, bone alkaline phosphatase and 25-hydroxyvitamin, 24h urinary excretion of calcium, potassium, magnesium and creatinine).
anthropometry: weight, measures DEXA for bone mass determination and body composition Isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF) Handgrip strength evalutation of the psychological profile with the brief Profile of Mood State (POMS) sexual life satisfaction evalutation with a Visual Analogue General Satisfaction Scale (VAS) physical examination: inspection of external genitalia (clitorides) and a visit to detect appearance of acne and gynecomastia
During the treatment phase all injections will be administered by the investigator or co-investigators for the entire study. Fasting (10 hours) blood samples will be taken (immediately before giving the injections) every time subjects come for injections (week 0, 6, 18, 30 and 42) and at the end of the treatment phase.
In the sexual and behavior questionnaire the subjects will judge their sexual activity and behavior in the period between visits. The subjects have the possibility to making additional comments about important events and disturbances.
In this pilot study, we evaluated the effects of testosterone and DHT on muscle strength, body composition, metabolism. Also cutaneous androgenic effects such as acne and androgenetic alopecia were evaluated.
DESIGN
For this purpose, in this randomized, double-blind placebo-controlled pilot trial we treated variectomized transmen for 54 weeks with:
* Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + a daily oral placebo pill (TU+PL)
* TU 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day (TU+DUT).
Prospective, phase III, randomized study design was used.
Subjects were seen every 12 weeks for safety monitoring that included evaluation of hematocrit, transaminases, alkaline phosphatases and bilirubin, creatinine, urea and serum electrolyte as potassium and sodium.
Baseline and week-54 evaluations included the following measurements:
blood drawings for measurements of: hormonal profile (serum testosterone, estradiol, luteinizing hormone and follicle-stimulating hormone, prolactin, sex hormone binding globulin, and thyroid stimulating hormone), haematocrit (Ht) and haemoglobin (Hb), glucidic and lipidic profile (fasting glucose, fasting insulin, total cholesterol, high- and low-density lipoproteins, and triglycerides), hepatic function (aspartate and alanine aminotransferases) and bone related markers (osteocalcin, parathyroid hormone, bone alkaline phosphatase and 25-hydroxyvitamin, 24h urinary excretion of calcium, potassium, magnesium and creatinine).
anthropometry: weight, measures DEXA for bone mass determination and body composition Isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF) Handgrip strength evalutation of the psychological profile with the brief Profile of Mood State (POMS) sexual life satisfaction evalutation with a Visual Analogue General Satisfaction Scale (VAS) physical examination: inspection of external genitalia (clitorides) and a visit to detect appearance of acne and gynecomastia
During the treatment phase all injections will be administered by the investigator or co-investigators for the entire study. Fasting (10 hours) blood samples will be taken (immediately before giving the injections) every time subjects come for injections (week 0, 6, 18, 30 and 42) and at the end of the treatment phase.
In the sexual and behavior questionnaire the subjects will judge their sexual activity and behavior in the period between visits. The subjects have the possibility to making additional comments about important events and disturbances.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: