A randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of FE 999049 for treatment of men with idiopathic infertility

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508430-34-00

Enrollment

197

Registered

2023-11-17

Start date

2023-01-12

Completion date

2024-10-23

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic male infertility (including oligoasthenozoospermia).

Brief summary

Spontaneous pregnancy observed in female partner within 9 months after randomisation of male subject, where spontaneous pregnancy is defined as vital pregnancy (documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound)

Interventions

DRUGREKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen

DRUGPre-filled pen containing 2.16mL solution

DRUGsubcutaneous injection

Eligibility

Sex/Gender

Male

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Spontaneous pregnancy observed in female partner within 9 months after randomisation of male subject, where spontaneous pregnancy is defined as vital pregnancy (documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound)	—

Countries

Belgium, Denmark, Germany, Italy, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026