Status:
WITHDRAWN
A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Amenorrhea
Fertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
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 lead...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
September 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT07152730
Start Date
September 12 2025
End Date
October 29 2025
Last Update
November 14 2025
Active Locations (1)
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1
Ferring Investigational Site
Miami, Florida, United States, 33172