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 groupLocations
1Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev., Herlev,2100, Herlev Denmark
Sponsors and collaborators
Martin Blomberg Jensen
Lead sponsor
Copenhagen University Hospital at Herlev
Sponsor institution
ReproNovo SA
Collaborator
Source ClinicalTrials.gov