Amenorrhea, Fertility, Infertility
Conditions
Keywords
Amenorrhea, Lutrepulse, Fertility, OmniPod
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.
Interventions
DRUGLutrepulse
Lutrepulse administered via the OmniPod delivery pump
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| t½; terminal elimination half-life from Part 2 - Pulse 6 | Up to 4 days |
| 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 |
| AUCtau: area under the concentration-time profile at steady-state from Part 2 - Pulse 6 | Up to 4 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 |
| t½; terminal elimination half-life from Part 1- Pulse 1 | Up to 5 days |
| tmax: time to maximum plasma concentration from Part 2 - Pulse 6 | Up to 4 days |
| λz; terminal elimination rate constant from Part 2 - Pulse 6 | Up to 4 days |
Countries
United States
Outcome results
None listed