Health TrialsbyHealthPanel

A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia

ConditionsInfertility Due to AzoospermiaInfertility, Male
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-55
SponsorMartin Blomberg Jensen

About this trial

This clinical interventional study aims to assess whether treatment with with leflutrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian hormone (AMH) or Inhibin B as a positive predictive biomarker.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent by participant

Signed informed consent by participant's partner (must just be obtained before the par-ticipant starts treatment at Visit 1), if applicable, regarding blood samples, data collec-tion about fertility treatment as well as pregnancy and pregnancy outcome

18-55 years

Azoospermia verified by at least 2 semen samples, average semen volume >= 1,0 ml with no identifiable sign of obstruction (samples taken at Visit -1 and at Visit 0 prior to confirmation of eligibility and dosing).

Disqualifiers

Klinefelter or other major genetic conditions including large deletions on sex chromosomes

Average testis size > 20 mL unless obstruction has been excluded

TESE procedure < ½ year ago

LH concentration > 15 IU/L at screening

Trial design

Design model

Single group

Treatments tested in this trial

  • Leflutrozole, Dose 2

    Drug

    Leflutrozole capsule 0.3 mg once weekly administered orally

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: LeflutrozoleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with spermatozoa in the ejaculate at Week 12-20.

The primary endpoint is proportion of patients with spermatozoa in the ejaculate at Week 20 (end-of-treatment).

Time frame
From enrollment to Week 20 (end-of-treatment)

Secondary outcomes

1

Change in serum reproductive hormones

Change in serum concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone, estradiol, inhibin B, anti-Müllerian hormone (AMH), and sex hormone-binding globulin (SHBG).

Time frame
Change from baseline to week 20 (end-of-treatment)
2

Change in seminal fluid reproductive biomarkers

Change in concentrations of RANK ligand (RANKL), osteoprotegerin (OPG), anti-Müllerian hormone (AMH), and inhibin B measured in seminal

Time frame
Change from baseline to week 20 (end-of-treatment)
3

Change in reproductive hormone ratios

Change in serum inhibin B/FSH ratio, testosterone/LH ratio, testosterone/estradiol ratio, and AMH/testosterone ratio.

Time frame
Change from baseline to week 20 (end-of-treatment)
4

Change in body mass index

Change in body mass index (BMI) weight and height will be combined to calculate BMI in kg/m\^2

Time frame
Change from baseline to week 20 (end-of-treatment)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Martin Blomberg Jensen

Lead sponsor

Copenhagen University Hospital at Herlev

Sponsor institution

ReproNovo SA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: