NCT05403476 is a Phase 2 clinical trial of FE 999049 in Male Idiopathic Infertility, sponsored by Ferring Pharmaceuticals.

Who is sponsoring NCT05403476?

NCT05403476 is sponsored by Ferring Pharmaceuticals.

What drugs are being tested in NCT05403476?

Interventions in NCT05403476: FE 999049, Placebo.

What condition does NCT05403476 study?

NCT05403476 studies Male Idiopathic Infertility.

Is NCT05403476 still recruiting?

NCT05403476 is currently terminated. Last updated 21 November 2024.

Last reviewed 2024-11-21 · How we verify

NCT05403476

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Terminated Phase 2 Last updated 21 November 2024

What this trial tests

Phase 2 trial testing FE 999049 in Male Idiopathic Infertility in 4 participants. Terminated before completion.

Timeline

16 August 2022

Primary endpoint
5 October 2024

23 October 2024

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	4
Start date	16 August 2022
Primary completion	5 October 2024
Estimated completion	23 October 2024
Sites	22 locations across Denmark, Italy, Belgium, Sweden, Germany, United States, Spain

Drugs / interventions tested

FE 999049 — full drug profile →
Placebo

Conditions studied

Male Idiopathic Infertility — all drugs for Male Idiopathic Infertility →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

Adults 18 to 50, male only, with Male Idiopathic Infertility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and safety of follitropin delta versus follitropin alpha/beta in infertility treatment: A systematic review and meta-analysis.
Komiya S, Watanabe J, Terayama T, Kamijo K, et al · · 2024 · cited 4× · PMID 38528991 · DOI 10.1002/rmb2.12573

Verify or expand the search:

Other trials of FE 999049

Trials testing the same drug.

NCT06173869 — A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 9990 · Phase 3 · completed

Other Ferring Pharmaceuticals trials

Trials by the same sponsor.

NCT07152730 — A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump · Phase 1 · withdrawn
NCT07029451 — To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patt · recruiting
NCT06668493 — Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis · Phase 1, PHASE2 · recruiting
NCT06545955 — A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in · Phase 3 · recruiting
NCT06510374 — Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Can · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05403476 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ferring Pharmaceuticals
Last refreshed: 21 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05403476.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing