Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000812493p
Ethics application status
Submitted, not yet approved
Date submitted
4/07/2025
Date registered
30/07/2025
Date last updated
30/07/2025
Date data sharing statement initially provided
30/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized Placebo-Controlled Clinical Trial for Recovery from Non-Prescribed Androgen Use
Scientific title
Randomized Placebo-Controlled Clinical Trial for Recovery from Non-Prescribed Androgen Use in Male Patients with androgen deficiency-type withdrawal symptoms
Secondary ID [1] 314816 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is related to previously registered studies ACTRN12621001751864 & ACTRN12621001753842. An amendment has been made to change the study drug and modify the study schedule.

Health condition
Health condition(s) or problem(s) studied:
Reproductive dysfunction secondary to androgen abuse 338072 0
Condition category
Condition code
Metabolic and Endocrine 334381 334381 0 0
Other endocrine disorders
Reproductive Health and Childbirth 334475 334475 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subcutaneous injections of 250 µg recombinant human chorionic gonadotrophin (HCG) (Ovidrel) once a week for 4 weeks. Administered in the department by a registered nurse involved in the study.
Intervention code [1] 331420 0
Treatment: Drugs
Comparator / control treatment
Subcutaneous injections of saline once a week for 4 weeks. Administered in the department by a registered nurse involved in the study.
Control group
Placebo

Outcomes
Primary outcome [1] 342061 0
Composite endpoint of serum Luteinising Hormone (LH) & Follicle Stimulating Hormone (FSH) recovery (composite recovery endpoint)
Timepoint [1] 342061 0
At week 4 (week of last injection) and week 8 (5 weeks after last injection)
Primary outcome [2] 342063 0
Whether participant has resumed androgen abuse
Timepoint [2] 342063 0
Weekly for 4 weeks whilst on treatment and at week 7 (4 weeks after last injection) and week 11 (7 weeks after last injection)
Secondary outcome [1] 449446 0
Time course of (a) serum (testosterone, dihydrotestosterone, estradiol, estrone) and urine (testosterone, estradiol) steroid profiles, (b) serum LH, FSH, AMH and inhibin B. This will be assessed as a composite outcome.
Timepoint [1] 449446 0
Weekly for 4 weeks whilst on treatment and at week 7 (4 weeks after last injection) and week 11 (7 weeks after last injection)
Secondary outcome [2] 449447 0
Sperm output and function during and after end of drug treatment. This will be assessed as a composite outcome.
Timepoint [2] 449447 0
Baseline (prior to first injection), week 4 (1 week after last injection) and week 11 (7 weeks after last injection)
Secondary outcome [3] 449448 0
Quality of life including psychosexual function
Timepoint [3] 449448 0
Baseline (prior to first injection), week 4 (1 week after last injection), week 7 (4 weeks after last injection) and week 11 (7 weeks after last injection)
Secondary outcome [4] 449450 0
Safety outcomes
Timepoint [4] 449450 0
Screening, baseline (prior to first injection) and end of study (7 weeks after last injection)
Secondary outcome [5] 449815 0
Safety blood tests at screening and end of study
Timepoint [5] 449815 0
Screening and end of study (7 weeks after last injection)
Secondary outcome [6] 450139 0
Quality of life including psychosexual function
Timepoint [6] 450139 0
Baseline (prior to first injection), week 4 (1 week after last injection), week 7 (4 weeks after last injection) and week 11 (7 weeks after last injection)
Secondary outcome [7] 450140 0
Quality of life including psychosexual function
Timepoint [7] 450140 0
Baseline (prior to first injection), week 4 (1 week after last injection), week 7 (4 weeks after last injection) and week 11 (7 weeks after last injection)
Secondary outcome [8] 450141 0
Quality of life including psychosexual function
Timepoint [8] 450141 0
Baseline (prior to first injection), week 4 (1 week after last injection), week 7 (4 weeks after last injection) and week 11 (7 weeks after last injection)

Eligibility
Key inclusion criteria
Male androgen abusers with characteristic androgen deficiency-type withdrawal symptoms (lethargy, easy fatigue, sexual dysfunction, male infertility) or likelihood of them developing
History of androgen abuse defined as having had at least two characteristic periods of using non-prescribed androgens within a year with the most recent ending more than 4 weeks prior to visit 2 (study week 0).
Intend to stop using any exogenous androgens during the study
Must have ceased androgen intake for at least one month
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 inability to provide consent such as due to major psychiatric disease or psychological condition that, in the investigator’s opinion, may limit understanding and compliance with the requirement of this study
Volunteer considered unlikely, in the investigator’s opinion, to complete study requirements

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)
Sequentially numbered, sealed opaque envelopes containing the code for the treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized 1:1 to a treatment group according to a computer-generated randomisation list prepared by someone not directly involved with either study drug administration or acquiring study endpoints (blood sampling, questionnaires).
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28183 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 44395 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 319377 0
Government body
Name [1] 319377 0
NHMRC
Country [1] 319377 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321862 0
None
Name [1] 321862 0
Address [1] 321862 0
Country [1] 321862 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317951 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 317951 0
Ethics committee country [1] 317951 0
Australia
Date submitted for ethics approval [1] 317951 0
26/06/2025
Approval date [1] 317951 0
Ethics approval number [1] 317951 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142662 0
Prof David Handelsman
Address 142662 0
Department of Andrology Building 22 Concord Hospital Concord NSW 2139
Country 142662 0
Australia
Phone 142662 0
+61 2 9767 7222
Fax 142662 0
Email 142662 0
[email protected]
Contact person for public queries
Name 142663 0
David Handelsman
Address 142663 0
Department of Andrology Building 22 Concord Hospital Concord NSW 2139
Country 142663 0
Australia
Phone 142663 0
+61 2 9767 7222
Fax 142663 0
Email 142663 0
[email protected]
Contact person for scientific queries
Name 142664 0
David Handelsman
Address 142664 0
Department of Andrology Building 22 Concord Hospital Concord NSW 2139
Country 142664 0
Australia
Phone 142664 0
+61 2 9767 7222
Fax 142664 0
Email 142664 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.