NCT05403476

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-08-16
• Primary completion: 2024-10-05
• Completion: 2024-10-23
• First posted: 2022-06-03
• Last updated: 2024-11-21

Locations

22 sites across 7 countries: United States, Belgium, Denmark, Germany, Italy, Spain, Sweden

Regulatory

• FDA-regulated drug study