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

Ferring Pharmaceuticals2 sites in 2 countries4 target enrollmentAugust 16, 2022

ConditionsMale Idiopathic Infertility

InterventionsFE 999049 Placebo

Overview

Phase: Phase 2
Intervention: FE 999049
Conditions: Male Idiopathic Infertility
Sponsor: Ferring Pharmaceuticals
Enrollment: 4
Locations: 2
Primary Endpoint: Spontaneous pregnancy observed in female partner within 9 months after randomization of male subject, where spontaneous pregnancy is defined as vital pregnancy
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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).

Registry

clinicaltrials.gov

Start Date

August 16, 2022

End Date

October 23, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.

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).

Arms & Interventions

FE 999049 (Follitropin Delta)

Intervention: FE 999049

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Spontaneous pregnancy observed in female partner within 9 months after randomization of male subject, where spontaneous pregnancy is defined as vital pregnancy

Time Frame: Up to 9 months after randomization

Vital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.

Secondary Outcomes

Time from randomization to spontaneous pregnancy observed in female partner in calendar time and number of menstrual cycles(Up to 9 months (End-of-Trial))
Changes in sperm concentration from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
Changes in luteinising hormone (LH) from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
Changes in inhibin B from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
Changes in testosterone from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
Changes in estradiol from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
Changes in total sperm count from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
Changes in total motile sperm count from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
Changes in follicle stimulating hormone (FSH) from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
Changes in sperm morphology from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
Changes in semen DNA fragmentation from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
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(Baseline to 6 and 9 months)
Changes in free testosterone concentration from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
Treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity(From randomization to 21-35 days after End-of-treatment)
Immune-related adverse events(From randomization to End-of-Trial (up to 9 months))
Positive Beta-Human Chorionic Gonadotropins (βhCG) (positive urine βhCG test) observed in female partner(Up to 9 months (End-of-Trial))
Changes in semen volume from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)