2025-524774-42-00招募中2 期
The NOVA-NOA Trial A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The primary endpoint is proportion of patients with spermatozoa in the ejaculate at Week 12-20.
研究概览
简要总结
The aim of this intervention is to investigate whether the aromatase inhibitor, Leflutrozole, can improve semen quality in a subgroup of infertile men
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
null
Test
干预措施: null (Drug)
结局指标
主要结局
The primary endpoint is 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 12-20.
次要结局
- Changes in BMI
- Changes in HbA1c, fasting- glucose, c-peptide, insulin and HOMA-IR
- Changes in lipids (total cholesterol, LDL, HDL and triglycerides)
- Changes in hematocrit
- Change in circulating markers of bone resorption and formation (PINP and CTX)
- Changes in serum reproductive hormones (FSH, LH, Testosterone, Estradiol, Inhibin B, AMH, SHBG)
- Changes in the concentration of RANKL, OPG, AMH, and Inhibin B in seminal fluid
- Change in serum Inhibin B/FSH ratio, Testosterone/LH ratio, Testosterone/Estradiol and AMH/Testosterone ratio
- Change in mineral homeostasis in spot urine (albumin, calcium, magnesium, iron, fer-ritin, phosphate, zinc, bicarbonate, citrate)
- Change in mineral homeostasis in serum (albumin, calcium, phosphate, magnesium, iron, ferritin, transferrin, hepcidin, zinc)
- Change in mineral homeostasis in seminal fluid (albumin, calcium, phosphate, magne-sium, iron, ferritin, zinc)
- Changes in calciotropic hormones (PTH, Klotho and FGF23)
- Changes in serum vitamin D metabolites (cholecalciferol, 25OHD, 24,25OHD, 1,25OH2D3 and cholecalciferol/25OHD ratio, 25OHD/24,25OHD ratio)
- Changes in androstenedione, cortisone and DHEAS
- Plasma and semen concentrations of leflutrozole in the participant and plasma concen-trations of leflutrozole in the female partner
- Change in sperm count, concentration, motility, and morphology when possible.
研究者
Martin Blomberg Jensen
Scientific
Herlev Hospital
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant ChemotherapyBreast CancerNCT07400523Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University446
招募中
不适用
Clinical Trial Evaluating the Efficacy and Implementation of an Early Adapted Physical Activity to Prevent and Manage Aromatase Inhibitor-induced Musculoskeletal Pain in Breast Cancer (APIS)Breast CancerNCT07295457Hospices Civils de Lyon182
招募中
3 期
Letrozole versus Mifepristone in abortion.CTRI/2024/07/070514AIIMS Patna294
尚未招募
2 期
Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.NCT07394946Cancer Care Hospital & Research Centre Foundation, Lahore126
尚未招募
不适用
Comparing Letrozole and Mifepristone for early pregnancy induced abortionsCTRI/2025/08/092186INHS ASVINI150