TransgenderismPhase 3DUTMUSCLE-20NCT04545450
Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen
A Phase 3 study testing dutasteride 5 mg/day and Testosterone Undecanoate in people with Transgenderism and Hypogonadism, run by Unita Complessa di Ostetricia e Ginecologia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transgenderism, Hypogonadism
- What is being tested?
- dutasteride 5 mg/day and Testosterone Undecanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2008to 15 Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Use of any drug known to affect biotransformation of testosterone and/or progestin, e.g. chlorcycline, phenobarbital, phenylbutazone, aminophenazone within the 30 days preceding the first administration of the test medication and during the study
- Use of oral anticoagulatory drugs within the 30 days preceding the first administration of the test medication and during the study
- Any oral or transdermal hormone medication within the 12 weeks preceding the first administration and during the study
- Probability of poor compliance and termination of the study
About this study
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
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
Read the 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.
- Conditions
- Transgenderism, Hypogonadism
- Being tested
- dutasteride 5 mg/day, Testosterone Undecanoate
- Keywords
- Muscle strenght, Testosterone, Dutasteride, dihydrotestosterone, 5a-reductase inhibitor
- Medical subject headings
- Transsexualism, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasteride 5 mg/dayDrug
Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate
Testosterone UndecanoateDrug
Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Undecanoate plus dutasteride | Active comparator | Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day Receives: 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 Receives: Drug: Testosterone Undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: At baseline and after 54 weeks of treatment
Secondary outcomes (9)
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
Measured: 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.
Measured: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: osteocalcin
Evaluation of serum osteocalcin (OC) change
Measured: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: parathyroid hormone
Evaluation of serum parathyroid hormone (PTH) changes
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: At baseline and after 54 weeks of treatment
Change in the lipid profile
Changes in triglycerides levels
Measured: At baseline and after 54 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start4 Nov 2008
- Primary completion30 Jul 2009
- Study completion15 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unita Complessa di Ostetricia e Ginecologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maria cristina meriggiola, Unita Complessa di Ostetricia e Ginecologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545450
- Sponsor's protocol ID
- DUTMUSCLE-20
- Acronym
- DUTMUSCLE-20
- Status last verified
- Sep 2020
- First submitted
- 10 Aug 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04545450
- Acronym / sponsor ID
- DUTMUSCLE-20 / DUTMUSCLE-20
- Conditions
- Transgenderism, Hypogonadism
- Keywords
- Muscle strenght, Testosterone, Dutasteride, dihydrotestosterone, 5a-reductase inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Unita Complessa di Ostetricia e GinecologiaUniversity, hospital or other
- Study start
- 4 Nov 2008 (actual)
- Primary completion
- 30 Jul 2009 (actual)
- Study completion
- 15 Oct 2010 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone Undecanoate plus dutasteride | Active comparator | Drug: dutasteride 5 mg/day, Drug: Testosterone UndecanoateTestosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day |
| Testosterone Undecanoate plus placebo | Placebo comparator | Drug: Testosterone UndecanoateTestosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + a daily oral placebo pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dutasteride 5 mg/dayAdministration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate | Drug | Testosterone Undecanoate plus dutasteride |
| Testosterone UndecanoateAdministration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate | Drug | Testosterone Undecanoate plus dutasteride, Testosterone Undecanoate plus placebo |
Primary outcome
Change in isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF)
Time frame: At baseline and after 54 weeks of treatment
Isokinetic peak torques were determined using isokinetic dynamometry (Biodex System 4 Pro, Medical Systems, Shirley, NY) at all four time points.
Change in handgrip strength
Time frame: At baseline and after 54 weeks of treatment
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
Change in body composition
Time frame: At baseline and after 54 weeks of treatment
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
Change in bone mineral density
Time frame: At baseline and after 54 weeks of treatment
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
Change in anthropometric assessment: BMI
Time frame: At baseline and after 54 weeks of treatment
weight, stature will be combined to report the BMI (kg/m^2)
Change in anthropometric assessment: waist-to-hip ratio
Time frame: At baseline and after 54 weeks of treatment
Waist and hip circumferences will be combined to report the waist-to-hip ratio (WHR)
9 secondary outcomes
Change in psychological profile with the brief Profile of Mood State (POMS)
Time frame: At baseline and after 54 weeks of treatment
Change in the satisfaction with their sexual life
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: osteocalcin
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: parathyroid hormone
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: bone alkaline phosphatase
Time frame: At baseline and after 54 weeks of treatment
Change in in the bone metabolism: urinary excretion of electrolites
Time frame: At baseline and after 54 weeks of treatment
Change in in the insulin resistance
Time frame: At baseline and after 54 weeks of treatment
Change in the lipid profile
Time frame: At baseline and after 54 weeks of treatment
Change in the lipid profile
Time frame: At baseline and after 54 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dutasteride 5 mg/day and Testosterone Undecanoate in people with Transgenderism and Hypogonadism, run by Unita Complessa di Ostetricia e Ginecologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF) (time frame: At baseline and after 54 weeks of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.