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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-12

Study Completion Date

2025-10-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Amenorrhea Fertility Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A (single dose)

Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse

Group Type EXPERIMENTAL

Lutrepulse

Intervention Type DRUG

Lutrepulse administered via the OmniPod delivery pump

Group B (multiple doses)

Part 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse

Group Type EXPERIMENTAL

Lutrepulse

Intervention Type DRUG

Lutrepulse administered via the OmniPod delivery pump

Interventions

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Lutrepulse

Lutrepulse administered via the OmniPod delivery pump

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes