NCT07152730

A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump

An Open-label Trial Investigating the PK of Gonadotropin Releasing Hormone (GnRH) Administrated Subcutaneously Via the OmniPod Delivery System in Healthy Female Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses. The results of this leads to anovulation and cessation of the menstrual cycle. Pulsatile GnRH has been widely used in the United States (US), Canada, and Europe for almost 40 years in the treatment of primary hypothalamic amenorrhea. It has a favorable safety profile and a high degree of effectiveness in enabling ovulation and spontaneous pregnancy. At the moment there are no other GnRH products on the market, nor are there any other drugs marketed for induction of ovulation in women with primary hypothalamic amenorrhea in the US, creating a clear unmet medical need. The goal of this trial is to characterize the exposure variability of GnRH when administered via the OmniPod.

Conditions

• Amenorrhea
• Fertility
• Infertility

Interventions

Type	Name	Description
DRUG	Lutrepulse	Lutrepulse administered via the OmniPod delivery pump

Timeline

• Start date: 2025-09-12
• Primary completion: 2025-10-29
• Completion: 2025-10-29
• First posted: 2025-09-03
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study