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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1313-1848 | Other Identifier | WHO |
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The decision to terminate development activities was based on business needs and unrelated to any safety or efficacy concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (single dose) | Experimental | Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutrepulse | Drug | Lutrepulse administered via the OmniPod delivery pump |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferring Investigational Site | Miami | Florida | 33172 | United States |
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| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| 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 |
| AUCtau: area under the concentration-time profile at steady-state from Part 2 - Pulse 6 | Up to 4 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 |
| t½; terminal elimination half-life from Part 2 - Pulse 6 | Up to 4 days |
| D000091642 | Urogenital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |