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

NCT07152730 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 000438U1111-1313-1848
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amenorrhea; Fertility; Infertility

Keywords

Amenorrhea; Lutrepulse; Fertility; OmniPod

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

Group A (single dose)

EXPERIMENTAL

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

Drug: Lutrepulse

Group B (multiple doses)

EXPERIMENTAL

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

Drug: Lutrepulse

Interventions

Lutrepulse DRUG

Lutrepulse administered via the OmniPod delivery pump

Group A (single dose); Group B (multiple doses)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects 18 to 40 years old (both included).
• Body mass index (BMI) between 18 and 30 kg/m2 (both included).
• Regular menstrual cycles of 24 to 35 days (both included).

You may not qualify if:

• Any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, or excretion of gonadotropin-releasing hormone (GnRH).
• Use of any hormonal contraceptives, growth hormone, insulin or thyroid hormone replacement therapy 30 days prior to dosing in this trial.
• Previously known or suspected hypersensitivity to GnRH.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Ferring Investigational Site

Miami, Florida, 33172, United States

Location

MeSH Terms

Conditions

Amenorrhea; Infertility

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 12, 2025
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)