Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial
Authors' conclusion
This RCT of leflutrozole in OHH demonstrated normalisation of TT in obese men. FSH/LH and semen parameter changes support that leflutrozole may preserve/improve testicular function.
Study context
- Population
- Men with obesity-associated hypogonadotropic hypogonadism: BMI 30–50 kg/m², morning total testosterone (TT) < 10.41 nmol/L, and two androgen deficiency symptoms (≥1 sexual dysfunction); mean BMI 38.1 kg/m², mean TT 7.97 nmol/L81 discontinued
- Participants
- 271 men
- Comparison
- Weekly leflutrozole vs placebo for 24 weeks
- Primary endpoint
- Normalisation of TT levels in ≥75% of patients
- Follow-up
- 24 weeks
Methodological detailsphase 2b, placebo-controlled, double-blind, multicentre (70 sites, Europe/USA)
- Phase 2b
- Placebo-controlled
- Double-blind
- Multicentre (70 sites, Europe/USA)
Primary result
As reported in the abstract
Mean TT
Secondary outcomes
Change in LH/FSH
- LH/FSH significantly increased with leflutrozole vs placebo
Body composition and sexual dysfunction
- No improvements in body composition or sexual dysfunction
Semen volume/total motile sperm count
- Improved with leflutrozole vs placebo
Safety
| Outcome | Leflutrozole 0.1 mg | Leflutrozole 0.3 mg | Leflutrozole 1.0 mg | Placebo |
|---|---|---|---|---|
| Lumbar BMD change | mean −1.24% | mean −1.30% | mean −2.09% | 0.66% |
Treatment-emergent adverse events
- More common with leflutrozole: raised haematocrit, hypertension, increased PSA, headache
Lumbar BMD change
- No change at the hip
Original publication
Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial. Eur J Endocrinol. Published 14 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →