Status:
TERMINATED
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)
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Male Idiopathic Infertility
Eligibility:
MALE
18-50 years
Phase:
PHASE2
Brief Summary
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 follicl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05403476
Start Date
August 16 2022
End Date
October 23 2024
Last Update
November 21 2024
Active Locations (22)
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1
Ferring Investigational Site
Tempe, Arizona, United States, 85284
2
Ferring Investigational Site
San Jose, California, United States, 95124
3
Ferring Investigational Site
Centennial, Colorado, United States, 80112
4
Ferring Investigational Site
Newark, Delaware, United States, 19713