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

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.

Study Overview

• Status: Withdrawn
• Conditions: Infertility; Amenorrhea; Fertility
• Intervention / Treatment: Drug: Lutrepulse

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33172
      • Ferring Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy female subjects 18 to 40 years old (both included).
2. Body mass index (BMI) between 18 and 30 kg/m2 (both included).
3. Regular menstrual cycles of 24 to 35 days (both included).

Exclusion Criteria

1. Any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, or excretion of gonadotropin-releasing hormone (GnRH).
2. Use of any hormonal contraceptives, growth hormone, insulin or thyroid hormone replacement therapy 30 days prior to dosing in this trial.
3. Previously known or suspected hypersensitivity to GnRH.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (single dose); Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse	Drug: Lutrepulse; Lutrepulse administered via the OmniPod delivery pump
Experimental: Group B (multiple doses); Part 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse	Drug: Lutrepulse; Lutrepulse administered via the OmniPod delivery pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax: maximum observed plasma concentration from Part 1- Pulse 1	Up to 5 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 1- Pulse 1	Up to 5 days
AUC0-infinity: area under the concentration-time curve to infinity from Part 1- Pulse 1	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax: time to maximum plasma concentration from Part 1- Pulse 1	Up to 5 days
λz; terminal elimination rate constant from Part 1- Pulse 1	Up to 5 days
t½; terminal elimination half-life from Part 1- Pulse 1	Up to 5 days
Cmax: maximum observed plasma concentration from Part 2 - Pulse 6	Up to 4 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 2 - Pulse 6	Up to 4 days
AUCtau: area under the concentration-time profile at steady-state from Part 2 - Pulse 6	Up to 4 days
tmax: time to maximum plasma concentration from Part 2 - Pulse 6	Up to 4 days
λz; terminal elimination rate constant from Part 2 - Pulse 6	Up to 4 days
t½; terminal elimination half-life from Part 2 - Pulse 6	Up to 4 days

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2025
• Primary Completion (Actual): October 29, 2025
• Study Completion (Actual): October 29, 2025

Study Registration Dates

• First Submitted: August 26, 2025
• First Submitted That Met QC Criteria: September 2, 2025
• First Posted (Estimated): September 3, 2025

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Fertility; Amenorrhea; OmniPod; Lutrepulse
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Infertility; Amenorrhea; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropin-Releasing Hormone
• Other Study ID Numbers: 000438; U1111-1313-1848 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No