MedTrace Logo

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 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-11-21

No results posted yet for this study

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

Interventions

DRUG

FE 999049

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2024-10-05
Completion
2024-10-23
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Germany
  • Italy
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403476 on ClinicalTrials.gov