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

Ferring

Status and phase: Withdrawn; Phase 1

Conditions: Infertility; Fertility; Amenorrhea

Treatments: Drug: Lutrepulse

Study type: Interventional

Funder types: Industry

Identifiers

NCT07152730

000438

U1111-1313-1848 (Other Identifier)

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group A (single dose)

Experimental group

Description:

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

Treatment:

Drug: Lutrepulse

Group B (multiple doses)

Experimental group

Description:

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

Treatment:

Drug: Lutrepulse