WithdrawnPhase 1

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

Stopped: The decision to terminate development activities was based on business needs and unrelated to any safety or efficacy concerns.

United States0Started 2025-09-12

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Cmax: maximum observed plasma concentration from Part 1- Pulse 1

Timeframe: Up to 5 days

AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 1- Pulse 1

Timeframe: Up to 5 days

AUC0-infinity: area under the concentration-time curve to infinity from Part 1- Pulse 1

Timeframe: Up to 5 days

Trial details

NCT IDNCT07152730

SponsorFerring Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-29

View on ClinicalTrials.gov More Amenorrhea trials

Plain-language summary

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Cmax: maximum observed plasma concentration from Part 1- Pulse 1

Timeframe: Up to 5 days

AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 1- Pulse 1

Timeframe: Up to 5 days

AUC0-infinity: area under the concentration-time curve to infinity from Part 1- Pulse 1

Timeframe: Up to 5 days