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)

NCT05403476 | Terminated Phase 2 FDA Drug

• 1 other identifier: 000400
• Study Type: interventional
• Target: 4
• Locations: 7 countries
• Sites: 22

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).

Conditions

Male Idiopathic Infertility

Outcome Measures

Primary Outcomes (1)

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

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

  Up to 9 months after randomization

Secondary Outcomes (17)

• Positive Beta-Human Chorionic Gonadotropins (βhCG) (positive urine βhCG test) observed in female partner

  Up to 9 months (End-of-Trial)

• 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 semen volume from pre-randomization to 3, 6, and 9 months after randomization

  From pre-randomization to 3, 6 and 9 months after randomization

• 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 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

Study Arms (2)

FE 999049 (Follitropin Delta)

EXPERIMENTAL

Drug: FE 999049

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

FE 999049 DRUG

FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.

Also known as: REKOVELLE, Follitropin Delta

FE 999049 (Follitropin Delta)

Placebo DRUG

Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (22)

Ferring Investigational Site

Tempe, Arizona, 85284, United States

Location

Ferring Investigational Site

San Jose, California, 95124, United States

Location

Ferring Investigational Site

Centennial, Colorado, 80112, United States

Location

Ferring Investigational Site

Newark, Delaware, 19713, United States

Location

Ferring Investigational Site

Chicago, Illinois, 60612, United States

Location

Ferring Investigational Site

Kansas City, Kansas, 66160, United States

Location

Ferring Investigational Site

New York, New York, 10065, United States

Location

Ferring Investigational Site

Raleigh, North Carolina, 27607, United States

Location

Ferring Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

Ferring Investigational Site

Bedford, Texas, 76022, United States

Location

Ferring investigational site

Webster, Texas, 77598, United States

Location

Ferring Investigational Site

Salt Lake City, Utah, 84108, United States

Location

Ferring Investigational Site

Seattle, Washington, 98195, United States

Location

Ferring Investigational Site

Brussels, Belgium

Location

Ferring Investigational Site

Copenhagen, Denmark

Location

Ferring Investigational Site

Halle, Germany

Location

Ferring Investigational Site

Münster, Germany

Location

Ferring Investigational Site

Modena, Italy

Location

Ferring Investigational Site

Rome, Italy

Location

Ferring Investigational Site

Valencia, Spain

Location

Ferring Investigational Site

Malmo, Sweden

Location

Ferring Investigational Site

Stockholm, Sweden

Location

MeSH Terms

Interventions

FE 999049; follitropin delta

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 3, 2022
• Study Start: August 16, 2022
• Primary Completion: October 5, 2024
• Study Completion: October 23, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (2); DE (2); SE (2); US (13); DK (1); BE (1)