Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001751864
Ethics application status
Approved
Date submitted
18/10/2021
Date registered
21/12/2021
Date last updated
25/11/2022
Date data sharing statement initially provided
21/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized Placebo-Controlled Clinical Trials on the Effect of Letrozole on Recovery from Non-Prescribed Androgen Use
Scientific title
Randomized Placebo-Controlled Clinical Trials on the Effect of Letrozole on Recovery from Non-Prescribed Androgen Use
Secondary ID [1] 305579 0
not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgen Abuse 323998 0
Condition category
Condition code
Metabolic and Endocrine 321503 321503 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral letrozole 2.5 mg tablet or an oral placebo tablet daily for 4 weeks
Intervention code [1] 321980 0
Treatment: Drugs
Comparator / control treatment
Placebo oral capsule with inert excipient material for the letrozole trial
Control group
Placebo

Outcomes
Primary outcome [1] 329272 0
Composite measure of recovery based on serum LH and FSH
Timepoint [1] 329272 0
4 weeks AFTER treatment finishes
Secondary outcome [1] 402595 0
Time course of Quality of life questionnaire (SF12)
Timepoint [1] 402595 0
at 4 and 8 weeks after post treatment
Secondary outcome [2] 403259 0
Time course of psychosexual function questionnaires (PDQ)
Timepoint [2] 403259 0
at 4 and 8 weeks post treatment
Secondary outcome [3] 403262 0
Time course of sexual function by questionnaire (IIEF)
Timepoint [3] 403262 0
at 4 and 8 weeks post treatment
Secondary outcome [4] 403266 0
Time course of mood changes by questionnaire (PHQ-9)
Timepoint [4] 403266 0
at 4 and 8 weeks post treatment
Secondary outcome [5] 403269 0
Time course of anxiety and mood changes by questionnaire ( HADS)
Timepoint [5] 403269 0
at 4 and 8 weeks post treatment

Eligibility
Key inclusion criteria
• Men over 18 years old in otherwise good health
• Characteristic androgen deficiency-type withdrawal symptoms (lethargy, easy fatigue, sexual dysfunction, male infertility)
• History of androgen abuse defined as having had at least two characteristic periods of using of non-prescribed androgens within a year with the most recent ending within the previous 4 weeks
• Intend to stop using any exogenous androgens by start of, and during, study
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• History of any chronic disease or condition requiring regular medical management
• History of hypothalamo-pituitary or testicular dysfunction unrelated to androgen abuse
• Allergic or other severe adverse reaction to hCG injections or letrozole and their ingredients
• History of major psychiatric disease or psychological condition that, in the investigator’s opinion, may limit understanding and compliance with the requirement of this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Standard analysis for RCT using linear mixed model for repeated measures with multiple covariates

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 35597 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 35598 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 309943 0
Government body
Name [1] 309943 0
NHMRC
Country [1] 309943 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 310981 0
Government body
Name [1] 310981 0
Sydney Local Health District
Address [1] 310981 0
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country [1] 310981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309659 0
Sydney Local Health District HREC (CRGH Zone)
Ethics committee address [1] 309659 0
Concord Repatriation General Hospital
Hospital Road, Concord NSW 2139
Ethics committee country [1] 309659 0
Australia
Date submitted for ethics approval [1] 309659 0
01/11/2021
Approval date [1] 309659 0
25/11/2021
Ethics approval number [1] 309659 0

Summary
Brief summary
AIMS OF THIS STUDY
To test model PCT-style regimens comprising either hCG or an antiestrogen, framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive function of abstinent androgen abusers.
These randomized double-blind placebo-controlled clinical trials are designed to test the efficacy and safety of pharmacological treatment as part of a future rehabilitation program for androgen abusers. To the best of our knowledge, no similar study has been undertaken or reported elsewhere.

OBJECTIVES
To investigate the efficacy of hCG or letrozole, an aromatase inhibitor, treatment over 4 weeks to accelerate recovery of the male reproductive system of abstinent androgen abusers at 4 and 8 weeks after cessation of trial drug treatment.

STUDY POPULATION
Androgen abusers who are planning to stop or have recently ceased androgen abuse will be recruited through local advertising, social media postings and word of mouth.

STUDY DESIGN
Randomized, double-blind, placebo-controlled, parallel group study with 4 weeks of drug (active or placebo) treatment.
The primary endpoint is the extent of recovery of the male reproductive system as indicated by a composite measure of serum LH and FSH at 4- and 8- weeks after cessation of study drug treatment.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 114938 0
Prof DJ Handelsman
Address 114938 0
Andrology Department, CRGH & ANZAC Research Institute,Hospital Road, CRGH 2139 NSW Australia
Country 114938 0
Australia
Phone 114938 0
+61 02 9767 7222
Fax 114938 0
Nil
Email 114938 0
djh@anzac.edu.au
Contact person for public queries
Name 114939 0
Prof DJ Handelsman
Address 114939 0
Andrology Department, CRGH & ANZAC Research Institute, Hospital Road, CRGH 2139 NSW, Australia
Country 114939 0
Australia
Phone 114939 0
+61 02 9767 7222
Fax 114939 0
Nil
Email 114939 0
djh@anzac.edu.au
Contact person for scientific queries
Name 114940 0
Prof DJ Handelsman
Address 114940 0
Andrology Department, CRGH & ANZAC Research Institute, Hospital Road, CRGH 2139 NSW Australia
Country 114940 0
Australia
Phone 114940 0
+61 02 9767 7222
Fax 114940 0
Nil
Email 114940 0
djh@anzac.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data including lab tests performed in NATA-accredited hospital laboratories. Some research analyses from non-NATA accredited labs may be shared
When will data be available (start and end dates)?
Start date after main paper is published, no end date
Available to whom?
All reasonable requests from suitably qualified investigators
Available for what types of analyses?
research
How or where can data be obtained?
From study PI (djh@anzac.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13627Study protocol  djh@anzac.edu.au
13628Ethical approval  djh@anzac.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.