Trial abstract · §2
GNRH-PULSATILE-HH — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Single-arm open-label study
- Masking
- None
- Arms
- 1
- Allocation
- Single arm; no randomisation
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Gonadorelin | — | — | Open-label active treatment; no randomised comparator |
| The randomised total is not recorded by the Institute and arm-level figures are therefore not presented. | |||
§2.3Population
Indication. Growth hormone deficiency and growth-hormone secretagogue pharmacology
Insufficient endogenous growth-hormone secretion, or the pharmacological stimulation of the growth-hormone axis, assessed here principally through provocative testing and IGF-1 response.
Geographic footprint. Israel · Japan.
§2.4Eligibility as the Institute reads it
- Included. Insufficient endogenous growth-hormone secretion, or the pharmacological stimulation of the growth-hormone axis, assessed here principally through provocative testing and IGF-1 response.
- Excluded. Participants for whom the intervention is contraindicated, including known hypersensitivity. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0145/2 · https://compoundevidence.com/trials/gnrh-pulsatile-hh/design/ · retrieved 30 July 2026