Idiopathic male infertility (including oligoasthenozoospermia) MedDRA version: 20.0 Level: PT Classification code 10021929 Term: Infertility male System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To investigate the effect of FE 999049 treatment of men with idiopathic infertility on the chance of spontaneous pregnancy in their female partners;Secondary Objective: - To investigate the effect of FE 999049 on semen parameters and endocrine profiles in men with idiopathic infertility - To evaluate the safety and immunogenicity of FE 999049 in men with idiopathic infertility;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: Within 9 months after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Positive ßhCG (positive urine ßhCG test) observed in female partner? - Time from randomisation to spontaneous pregnancy observed in female partner in calendar time and number of menstrual cycles - Changes in semen parameters (semen volume, sperm concentration, total count, motility, morphology, and DNA fragmentation) from prerandomisation to 3, 6, and 9 months after randomisation - Treatment responders defined by either spontaneous pregnancy observed in female partner, or increase of total sperm count or total motile sperm count to 50% over average baseline at 6 and/or 9 months - Changes in serum hormone concentrations (follicle-stimulating hormone [FSH], luteinising hormone [LH], inhibin B, testosterone, and estradiol) from randomisation to 3 and 6 months after randomisation - Changes in free testosterone concentration from randomisation to 3 and 6 months after randomisation - Treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity - Immune-related adverse events;Timepoint(s) of evaluation of this end point: Timepoint as indicated in each applicable endpoint. | — |
Countries
Denmark, Germany, Italy, Spain, Sweden, United States
Contacts
Public ContactGlobal Clinical Development
Ferring Pharmaceuticals A/S
Outcome results
None listed