Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001753842p
Ethics application status
Submitted, not yet approved
Date submitted
23/11/2021
Date registered
21/12/2021
Date last updated
21/12/2021
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 human chorionic gonadotrophin (hCG) on Recovery from Non-Prescribed Androgen Use
Scientific title
Randomized Placebo-Controlled Clinical Trials on the Effect of human chorionic gonadotrophin (hCG) on Recovery from Non-Prescribed Androgen Use
Secondary ID [1] 305869 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgen abuse 324418 0
Condition category
Condition code
Metabolic and Endocrine 321915 321915 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single subcutaneous injection of:
hCG in a dose of 5000 IU or saline placebo once a week for 4 weeks. The injection will be administered by study staff at the study site and documented as given or otherwise.
Intervention code [1] 322265 0
Treatment: Drugs
Comparator / control treatment
Saline placebo injected subcutaneously.
Control group
Placebo

Outcomes
Primary outcome [1] 329657 0
Composite measure of recovery based on serum LH and FSH
Timepoint [1] 329657 0
4 weeks AFTER treatment finishes
Secondary outcome [1] 403328 0
Time course of Quality of life (SF12) questionnaires.
Timepoint [1] 403328 0
at 4 and 8 weeks after post treatment
Secondary outcome [2] 403329 0
Time course of Quality of life (PDQ) questionnaires
Timepoint [2] 403329 0
at 4 and 8 weeks post treatment
Secondary outcome [3] 403330 0
Time course of Quality of life and psychosexual function questionnaires (IIEF)
Timepoint [3] 403330 0
at 4 and 8 weeks post treatment
Secondary outcome [4] 403331 0
Time course of changes in mood (PHQ-9)
Timepoint [4] 403331 0
at 4 and 8 weeks post treatment
Secondary outcome [5] 403332 0
Time course of onset of anxiety and depression, if any, using HADS questionnaires
Timepoint [5] 403332 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 nonprescribed 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
10/01/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
1/04/2023
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21385 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 36051 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 310220 0
Government body
Name [1] 310220 0
NHMRC
Country [1] 310220 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District (SLHD)
Address
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 311579 0
None
Name [1] 311579 0
Address [1] 311579 0
Country [1] 311579 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309903 0
Sydney Local Health District HREC (CRGH Zone)
Ethics committee address [1] 309903 0
Concord Repatriation General Hospital
Hospital Road, Concord NSW 2139
Ethics committee country [1] 309903 0
Australia
Date submitted for ethics approval [1] 309903 0
01/11/2021
Approval date [1] 309903 0
Ethics approval number [1] 309903 0

Summary
Brief summary
AIMS OF THIS STUDY
To test model PCT-style regimen of hCG , framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive
function of abstinent androgen abusers.
This randomized double-blind placebo-controlled clinical trial is designed to test the efficacy and safety of a 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 weekly hCG 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 115778 0
Prof David J Handelsman
Address 115778 0
Andrology Department, CRGH & ANZAC Research Institute, Hospital Road, CRGH NSW 2139 Australia
Country 115778 0
Australia
Phone 115778 0
+61 2 9767 7222
Fax 115778 0
+61 2 9767 7221
Email 115778 0
djh@anzac.edu.au
Contact person for public queries
Name 115779 0
Prof David J Handelsman
Address 115779 0
Andrology Department, CRGH & ANZAC Research Institute, Hospital Road, CRGH NSW 2139 Australia
Country 115779 0
Australia
Phone 115779 0
+61 2 9767 7222
Fax 115779 0
+61 2 9767 7221
Email 115779 0
djh@anzac.edu.au
Contact person for scientific queries
Name 115780 0
Prof David J Handelsman
Address 115780 0
Andrology Department, CRGH & ANZAC Research Institute, Hospital Road, CRGH NSW 2139 Australia
Country 115780 0
Australia
Phone 115780 0
+61 2 9767 7222
Fax 115780 0
+61 2 9767 7221
Email 115780 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)?
Available from study completion with no end date determined.
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
14195Study protocol  djh@anzac.edu.au
14196Ethical 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.