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

Ferring Pharmaceuticals

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Amenorrhea Fertility Infertility

Interventions

LutrepulseDRUG

Lutrepulse administered via the OmniPod delivery pump

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ferring Investigational Site

Miami, Florida, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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