RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-label Trial Investigating the PK of Gonadotropin Releasing Hormone (GnRH) Administrated Subcutaneously Via the OmniPod Delivery System in Healthy Female Subjects

Quick Facts

Study Start:2025-09-12
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07152730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Healthy female subjects 18 to 40 years old (both included).
  2. 2. Body mass index (BMI) between 18 and 30 kg/m2 (both included).
  3. 3. Regular menstrual cycles of 24 to 35 days (both included).
  4. 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).
  5. 2. Use of any hormonal contraceptives, growth hormone, insulin or thyroid hormone replacement therapy 30 days prior to dosing in this trial.
  6. 3. Previously known or suspected hypersensitivity to GnRH.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Global Clinical Compliance
CONTACT
1-888-337-7464
Disclosure@ferring.com

Principal Investigator

Global Clinical Compliance
STUDY_DIRECTOR
Ferring Pharmaceuticals

Study Locations (Sites)

Ferring Investigational Site
Miami, Florida, 33172
United States

Collaborators and Investigators

Sponsor: Ferring Pharmaceuticals

  • Global Clinical Compliance, STUDY_DIRECTOR, Ferring Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-12
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2025-09-12
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • Amenorrhea
  • Lutrepulse
  • Fertility
  • OmniPod

Additional Relevant MeSH Terms

  • Amenorrhea
  • Fertility
  • Infertility