KISS-DIAGNOSTIC-DDI — design and population
Design, allocation, arms and the population enrolled.
Institute-constructed programme record. This document is not a report of a published trial. It is a record the Institute has constructed to represent an instalment, sub-study or extension of a real development programme, published in order to carry a methodological point that the parent trial report does not address. No effect estimate on this page is attributable to any publication, and its reference-list entry carries a programme-record label rather than a citation. The policy governing these records was settled through a public comment period.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, crossover
- Masking
- Double-blind with a washout between periods
- Arms
- 2
- Allocation
- Randomised to treatment sequence, with a washout between periods
- 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 |
|---|---|---|---|
| Kisspeptin-10 | — | — | Intervention at the dose reached after titration |
| Placebo | — | — | Matched placebo, administered on the same schedule |
| 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. Denmark · France · Brazil · Argentina · China.
§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 not established — no marketing authorisation. 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.