A Phase 3 interventional study of dutasteride 5 mg/day and Testosterone Undecanoate in Transgenderism and Hypogonadism, sponsored by Unita Complessa di Ostetricia e Ginecologia. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Unita Complessa di Ostetricia e Ginecologia · Phase 3, Interventional, and Treatment
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
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:
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.
345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.
This study's enrollment of 16 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →Unita Complessa di Ostetricia e Ginecologia is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day
Drug: dutasteride 5 mg/day · Drug: Testosterone Undecanoate
Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + a daily oral placebo pill
Drug: Testosterone Undecanoate
Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate
Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate
Change in isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF)
Isokinetic peak torques were determined using isokinetic dynamometry (Biodex System 4 Pro, Medical Systems, Shirley, NY) at all four time points.
Time frame: At baseline and after 54 weeks of treatment
Change in handgrip strength
Three trials of three sets of maximal isometric handgrip on a mechanical dynamometer (model Grip-A, Takei Physical Fitness Test TKK 5001, Japan), alternately with the dominant and non-dominant hand, with a three minute rest between each trial
Time frame: At baseline and after 54 weeks of treatment
Change in body composition
Dual-energy X-ray absorptiometry was performed using the Hologic 49159 densitometer and standard QDR body composition software (Model QDR4500W, Software Level 11.2, Hologic Spine; Hologic, Bedford, MA) for the measurement of body fat and lean mass
Time frame: At baseline and after 54 weeks of treatment
Change in bone mineral density
Dual-energy X-ray absorptiometry was performed using the Hologic 49159 densitometer and standard QDR body composition software (Model QDR4500W, Software Level 11.2, Hologic Spine; Hologic, Bedford, MA) for the evaluation of bone mineral density at lumbar and femoral site
Time frame: At baseline and after 54 weeks of treatment
Change in anthropometric assessment: BMI
weight, stature will be combined to report the BMI (kg/m\^2)
Time frame: At baseline and after 54 weeks of treatment
Change in anthropometric assessment: waist-to-hip ratio
Waist and hip circumferences will be combined to report the waist-to-hip ratio (WHR)
Time frame: At baseline and after 54 weeks of treatment
Change in psychological profile with the brief Profile of Mood State (POMS)
The POMS is a self-reporting questionnaire consisting of 30 items in six categories: tension-anxiety, depression, anger-hostility, vigor, fatigue and confusion, which are scored from 1-4 according to severity
Time frame: At baseline and after 54 weeks of treatment
Change in the satisfaction with their sexual life
using a Visual Analogue General Satisfaction Scale (VAS). A VAS for satisfaction is a horizontal line of 10-cm long. At the start and finish there are two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). Subjects respond to the question 'Are you satisfied with your sexual life now?' and rate their satisfaction by making a vertical mark on the 100-mm line. The measurement in millimeters is converted to the same number of points ranging from zero to 10 points.
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: osteocalcin
Evaluation of serum osteocalcin (OC) change
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: parathyroid hormone
Evaluation of serum parathyroid hormone (PTH) changes
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: bone alkaline phosphatase
Evaluation of serum bone alkaline phosphatase (BAP) changes
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: urinary excretion of electrolites
Changes in the 24h urinary excretion of electrolites
Time frame: At baseline and after 54 weeks of treatment
Change in in the insulin resistance
Change in the HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Time frame: At baseline and after 54 weeks of treatment
Change in the lipid profile
Changes in cholesterol (Tot Chol and high- and low-density lipoproteins) levels
Time frame: At baseline and after 54 weeks of treatment
Change in the lipid profile
Changes in triglycerides levels
Time frame: At baseline and after 54 weeks of treatment
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Unita Complessa di Ostetricia e Ginecologia