Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00455260 | A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency | PHASE1 | COMPLETED | 60 | — | — | Apr 1, 2007 | - | Sep 2, 2013 | - | — |
| Name | Type | Description |
|---|---|---|
| hGH-ViaDerm™ System (hGH or somatropin) | DRUG | transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day) |
| hGH-ViaDerm™ System | DEVICE | The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin). The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system. |
Inclusion Criteria: Ages Eligible for Study: 20 Years - 60 Years, Genders Eligible for Study: Both 1. Clinical diagnosis of Adult Growth Hormone Deficiency (AGHD) meeting one of the following criteria: * Three or more additional pituitary hormone deficiencies, based on well documented medical ...