EUCTR2021-004254-37-ES进行中（未招募）1 期
A randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of FE 999049 for treatment of men with idiopathic infertility - ADAM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •History of infertility for 12-60 months with current partner at randomisation.
- •Men between the ages of 18 and 50 years.
- •Total sperm count 5-39 million at screening; confirmed by two consecutive samples taken =2 weeks apart before randomisation.
- •Total motile sperm count of 5-16 million at screening; confirmed by two consecutive samples taken =2 weeks apart before randomisation.
- •Semen volume =1.4 mL at screening; confirmed by two consecutive samples taken =2 weeks apart before randomisation.
- •Serum follicle-stimulating hormone (FSH) levels of 1.5-8.0 IU/L (measured at central laboratory) at screening.
- •Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at central laboratory) at screening.
- •Serum total testosterone levels of =300 ng/dL (equals =10.4 nmol/L; measured at central laboratory) at screening.
- •Agree to have regular intercourse with current female partner with the intent of spontaneous conception within 9 months from randomisation.
- •Agree to provide information on female partner's positive urine pregnancy test(s) and documentation of ultrasound(s), delivery, and neonatal/infant health.
- •Current partner fulfilling the criteria below:
- •- Pre-menopausal woman between the ages of 18 and 35 years.
- •- Regular menstrual cycles of 21-35 days.
- •- No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation.
- •- Agree not to obtain infertility treatment outside of this trial for 9 months from randomisation of male subject.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous FSH treatment not leading to conception.
- •Past or current use of finasteride within 3 months prior to screening.
- •Any history of anatomical disorder of the pituitary gland or testes.
- •Any structural abnormalities of the vas deferens (unilateral or bilateral) at screening.
- •Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact fertility.
- •Known history or presence of clinical varicocele (subclinical and Grade 1 varicocele are acceptable).
- •Known history of cryptorchidism, testicular torsion, or orchitis.
- •Known abnormal karyotype (including Y-chromosome microdeletion).
- •Current or past treatment of urogenital (kidney, bladder, testicular, or prostate) cancer as well as history of chemo- or radiotherapy that can have impact on testes.
- •Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders).
- •Administration of hormonal preparations, agents known to impair testicular function or affect sex hormone secretion, and known or suspected teratogens within 3 months prior to screening. Administration of anabolic steroids within 12 months prior to screening.
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