A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

A Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of FE 999049 for Treatment of Men With Idiopathic Infertility

The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment). For more information, please visit the trial's website www.adamclinicaltrial.com (only applicable in the US).

Inclusion Criteria:

• History of infertility with current partner at randomisation must be 12-60 months if current partner is aged <35 years or 6-60 months if current partner is aged 35-38 years.
• 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 randomization.
• Total sperm motility of ≥10% at screening; confirmed by two samples taken ≥2 weeks apart before randomisation. If a semen sample has been taken within 3 months prior to screening and been analysed at an andrology laboratory, it can be included as the first of the two semen samples at screening.
• Semen volume ≥1.4 mL at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization.
• Serum follicle-stimulating hormone (FSH) levels of 2-12.0 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 randomization.
• 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 38 years (both inclusive) at the time of randomisation of male participant.
• 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 6 months from randomization of male subject.

Exclusion Criteria:

• Previous FSH treatment for ≥4 months 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.