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

NCTNCT07152730Other id000438Other idU1111-1313-1848

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: The decision to terminate development activities was based on business needs and unrelated to any safety or efficacy concerns.

Overview

Status: Withdrawn
Phase: Phase 1
Enrollment: 0 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 12 Sept 2025
Primary completion: 29 Oct 2025
Completion: 29 Oct 2025
First posted: 3 Sept 2025
Last update posted: 14 Nov 2025
Conditions: Amenorrhea · Fertility · Infertility

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026

Ph 1
A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump
NCT07152730
12 Sept 2025 to 29 Oct 2025
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LutrepulseDrug

Arms2

Experimental
Group A (single dose)
Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse
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

Primary outcomes3

Outcomes the sponsor listed as primary.

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

Secondary outcomes(9)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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