A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia (NCT07571928) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Denmark15 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
* Serum AMH or Inhibin B level above the lower limit of quantification (LLOQ) at screening or within 6 months prior to screening
* Testosterone \< 15 nmol/L at screening or within 6 months prior to screening
* Serum estradiol above the lower limit of normal range (48 pmol/L) at screening or within 6 months prior to screening
Exclusion Criteria:
* 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
* Current abuse of steroids
* BMI \> 45 kg/m2
* Severe chronic diseases requiring daily medication
* Prior thromboembolic event within the last 24 months
* Cardiovascular event within the last 6 months judged as significant by the investigator
* Osteoporosis requiring medical treatment
* Use of any prescription or non-prescription medication (apart from routine vitam…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with spermatozoa in the ejaculate at Week 12-20.
Timeframe: From enrollment to Week 20 (end-of-treatment)