Changes in 17-OHP levels in men with previous anabolic steroid use
Research type
Research Study
Full title
Investigating the dose-response relationship between serum testosterone and levels of 17-hydroxyprogesterone in men with anabolic-steroid-induced hypogonadism.
IRAS ID
334394
Contact name
Channa Jayasena
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Testosterone is a naturally occurring hormone needed for sexual function, fertility, muscle mass and mood in men. Anabolic steroids (AAS) are testosterone-like drugs that copy the effects of testosterone and may be misused in high doses to increase muscle growth.
AAS are known to suppress natural testosterone production from the testes. Suddenly stopping AAS can cause low testosterone (hypogonadism) which might take months to years to recover. A difficulty in assessing men with hypogonadism after AAS use is correctly interpreting levels of testosterone in men who have previously administered AAS. It is not possible with current testing to differentiate between natural testosterone and exogenous testosterone.
17-hydroxyprogesterone (17-OHP) is a precursor hormone to testosterone, also made in the testes. Previous studies have suggested that 17-OHP levels are lower in men administered testosterone. We want to investigate how 17-OHP levels change in men with hypogonadism from previous AAS use during varying doses of testosterone administration.
We will conduct the study at the Clinical Research Facility at Imperial College London and selected harm reduction clinics. We will ask participants to complete a questionnaire about AAS use and perform blood tests including testosterone and 17-OHP. We will recruit 80 men (20 each for different doses and placebo) who have stopped AAS within the last 1-6 months and have low blood testosterone levels.
We will randomly allocate participants to one of the four groups (different doses of testosterone/ placebo). Men will not be told their group. We will provide four doses for weekly self-injections. In 4 weeks (end of the study), we will ask men to complete the questionnaire again and we will repeat blood samples.
This study will investigate if 17-OHP levels are a useful marker of exogenous testosterone administration which could be invaluable in the diagnosis of hypogonadism due to AAS use.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0148
Date of REC Opinion
29 Jul 2024
REC opinion
Further Information Favourable Opinion