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

Not Applicable

Recruiting

• Conditions: Amenorrhea; Fertility; Infertility
• Interventions: Drug: Lutrepulse

• Registration Number: NCT07152730
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-09-02
• Study First Posted: 2025-09-03
• Study Start: 2025-09-12
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (single dose)	Lutrepulse	Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse
Group B (multiple doses)	Lutrepulse	Part 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ferring Investigational Site; 🇺🇸 Miami, Florida, United States