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The NOVA-NOA Trial A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
EU CTIS ID: 2025-524774-42-00
What this study is testing
The aim of this intervention is to investigate whether the aromatase inhibitor, Leflutrozole, can improve semen quality in a subgroup of infertile men
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent by participant
- Signed informed consent by participant’s partner (must just be obtained before the participant starts treatment at Visit 1), if applicable, regarding blood samples, data col-lection 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
You likely can't join if
- Klinefelter or other major genetic conditions including large deletions on sex chromo-somes
- Osteoporosis requiring medical treatment
- Use of any prescription or non-prescription medication (apart from routine vitamins, occasional use of paracetamol, acetylsalicylic acid, or ibuprofen) which could interfere with pharmacokinetic or pharmacodynamic results, as judged by the investigator, such as: o Herbal products and non-routine vitamins o Insulin o Medication such as systemic corticosteroids, tricyclic antidepressants, and atypical antipsychotics
- Surgery scheduled for the trial duration period, except for minor, non-gastrointestinal surgical procedures at the discretion of the investigator
- Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator’s opinion could interfere with the results of the trial
- Serum prostate specific antigen (PSA) > 3 ng/mL at screening or within 6 months prior to screening
See the full eligibility criteria
Who can join
- Signed informed consent by participant
- Signed informed consent by participant’s partner (must just be obtained before the participant starts treatment at Visit 1), if applicable, regarding blood samples, data col-lection 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
What rules you out
- Klinefelter or other major genetic conditions including large deletions on sex chromo-somes
- Osteoporosis requiring medical treatment
- Use of any prescription or non-prescription medication (apart from routine vitamins, occasional use of paracetamol, acetylsalicylic acid, or ibuprofen) which could interfere with pharmacokinetic or pharmacodynamic results, as judged by the investigator, such as: o Herbal products and non-routine vitamins o Insulin o Medication such as systemic corticosteroids, tricyclic antidepressants, and atypical antipsychotics
- Surgery scheduled for the trial duration period, except for minor, non-gastrointestinal surgical procedures at the discretion of the investigator
- Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator’s opinion could interfere with the results of the trial
- Serum prostate specific antigen (PSA) > 3 ng/mL at screening or within 6 months prior to screening
- Hematocrit >50% at screening or within 6 months prior to screening
- Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the trial, as judged by the investigator
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.