2023-508430-34-00已完成2 期
A randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of FE 999049 for treatment of men with idiopathic infertility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 10
- 主要终点
- Spontaneous pregnancy observed in female partner within 9 months after randomisation of male subject, where spontaneous pregnancy is defined as vital pregnancy (documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound)
研究概览
简要总结
To investigate the effect of FE 999049 treatment of men with idiopathic infertility on the chance of spontaneous pregnancy in their female partners.
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
- 否
入选标准
- •History of infertility for 12-60 months with current partner at 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: a) Pre-menopausal woman between the ages of 18 and 35 years. b) Regular menstrual cycles of 21-35 days. c) No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation. d) Agree not to obtain infertility treatment outside of this trial for 9 months from randomisation of male subject.
- •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 sperm motility of ≥10% 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
排除标准
- •Previous FSH treatment not leading to conception
- •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
- •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
结局指标
主要结局
Spontaneous pregnancy observed in female partner within 9 months after randomisation of male subject, where spontaneous pregnancy is defined as vital pregnancy (documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound)
Spontaneous pregnancy observed in female partner within 9 months after randomisation of male subject, where spontaneous pregnancy is defined as vital pregnancy (documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound)
次要结局
未报告次要终点
研究者
Sarah Grover
Scientific
Ferring Pharmaceuticals A/S
研究点 (10)
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