Trial abstract
KISS-DIAGNOSTIC — structured trial abstract
KISS-DIAGNOSTIC — Kisspeptin-10 in gh axis: diagnostic accuracy
§1Structured abstract
§1.1Objective
To evaluate Kisspeptin-10 in growth hormone deficiency and growth-hormone secretagogue pharmacology, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Diagnostic accuracy study of a stimulation test
- Masking
- Assessor-blinded
- Phase
- Phase 1
- Randomised participants
- not recorded by the Institute
- Duration of the primary analysis period
- Single test
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Luteinising-hormone response to a kisspeptin challenge as a test of hypothalamic function
§1.4Principal result
A reproducible luteinising-hormone response used as a research probe of hypothalamic function.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Not held | Not recorded by the Institute. The field is left empty rather than estimated. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
Compound Evidence Institute · CEI-TR-0141 · https://compoundevidence.com/trials/kiss-diagnostic/ · retrieved 30 July 2026