Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen

NCT04545450 | Completed Phase 3

• 1 other identifier: DUTMUSCLE-20
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Conditions

Transgenderism; Hypogonadism

Keywords

Muscle strenght; Testosterone; Dutasteride; dihydrotestosterone; 5a-reductase inhibitor

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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

  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

  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)

  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)

  At baseline and after 54 weeks of treatment

Secondary Outcomes (9)

• Change in psychological profile with the brief Profile of Mood State (POMS)

  At baseline and after 54 weeks of treatment

• Change in the satisfaction with their sexual life

  At baseline and after 54 weeks of treatment

• Change in in the bone metabolism: osteocalcin

  At baseline and after 54 weeks of treatment

• Change in in the bone metabolism: parathyroid hormone

  At baseline and after 54 weeks of treatment

• Change in in the bone metabolism: bone alkaline phosphatase

  At baseline and after 54 weeks of treatment

Study Arms (2)

Testosterone Undecanoate plus dutasteride

ACTIVE COMPARATOR

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 plus placebo

PLACEBO COMPARATOR

Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + a daily oral placebo pill

Drug: Testosterone Undecanoate

Interventions

dutasteride 5 mg/day DRUG

Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate

Testosterone Undecanoate plus dutasteride

Testosterone Undecanoate DRUG

Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate

Testosterone Undecanoate plus dutasteride; Testosterone Undecanoate plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy transmen
• Previous bilateral gonadectomy during sex reassigning surgery
• Body Mass Index (BMI) between 20 and 29 kg/m²; (body weight in kilograms divided by body height in meters squared)
• Clinical examination without pathological findings relevant to the study
• No concomitant use of drugs known to affect the hypothalamic-pituitary-ovarian axis
• Written Consent Form
• High probability of a good compliance and termination of the study

You may not qualify if:

• Participation in another clinical trial within the 30 days preceding the first administration
• Simultaneous participation in another clinical trial
• Subjects institutionalized or imprisoned by order of the court
• Subject who compete in sports
• Subjects reporting desire to perform regular physical exercises for the duration of the study
• Serious organic or psychic disease suspected from history and/or clinical examination
• Diseases (especially tumors) that might represent an actual contraindication for testosterone
• Past or present history of thrombotic or embolic diseases
• Arterial hypertension
• Diabetes mellitus
• Acute or chronic hepatic diseases
• Manifest renal diseases with renal dysfunction
• Severe internal diseases
• Biochemical and/or hematological laboratory values beyond normal ranges unless the Investigator confirms that the deviations are of no clinical relevance
• Any indication of chronic use of drugs, alcohol, opiates or recreational drugs

Sponsors & Collaborators

• Unita Complessa di Ostetricia e Ginecologia: lead

MeSH Terms

Conditions

Transsexualism; Hypogonadism

Interventions

Dutasteride; testosterone undecanoate

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the research pharmacist was aware of the randomization results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: September 11, 2020
• Study Start: November 4, 2008
• Primary Completion: July 30, 2009
• Study Completion: October 15, 2010
• Last Updated: September 11, 2020

Record last verified: 2020-09