A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With L… (NCT05205837) | Clinical Trial Compass
TerminatedPhase 4
A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial
Stopped: Lack of recruitment
Denmark8 participantsStarted 2021-11-24
Plain-language summary
The overall objective of this randomized trial is to investigate the effects of treatment of AAS- induced male hypogonadism with combined therapy of letrozole and hCG compared with placebo on reproductive hormone levels, adherence to cessation of AAS use, fertility, cardiac function and quality of life.
Who can participate
Age range18 Years – 50 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Male sex
* 18 - 50 years of age
* Hypogonadism following observational period of a minimum of 12 weeks since AAS discontinuation OR hypogonadism with a urine sample negative for AAS analyses at screening visit: plasma total testosterone ≤ 10 nmol/L AND featuring at least one symptom of male hypogonadism using IIEF in terms of erectile function (IIEF: Q1 - Q5 + Q15; total score \< 26) and/or sexual desire (IIEF: Q11 + Q12; total \< 7) (1) and/or ADAM questionnaire (YES to three questions other than question 1 and 7) and/or regular use of medical treatment for erectile dysfunction.
* Motivation for permanent AAS cessation
Exclusion Criteria:
* Established cardiovascular disease
* Established diabetes of any kind 384
* Congenital hypogonadal conditions (cryptorchidism, Klinefelter's disease, Kallmann's disease etc.)
* Previous established hypogonadal conditions due to other causes than illicit use of AAS
* Current or previous treatment with testosterone on other indication than AAS-induced male hypogonadism
* Abnormal puberty development (small testes, late or absent pubic hairing, late or absent deepening of voice, etc.)
* Current or previous pituitary diseases including pituitary tumors
* Current or previous tumors of the hypothalamus
* Current or former testicular cancer
* Current or previous prostate cancer
* Current or previous breast cancer
* Other cancers unless complete remission ≥ 5 year
* Other concomitant dise…
What they're measuring
1
Change in plasma total testosterone concentration after 24 weeks from baseline