A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
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
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
Treatments tested in this trial
- Leflutrozole, Dose 2
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Martin Blomberg Jensen
Lead sponsor
Copenhagen University Hospital at Herlev
Sponsor institution
ReproNovo SA
Collaborator
Source ClinicalTrials.gov