GNRH-PULSATILE-HH — structured trial abstract
GNRH-PULSATILE-HH — Gonadorelin in gh axis: single-arm open-label
§1Structured abstract
§1.1Objective
To evaluate Gonadorelin in growth hormone deficiency and growth-hormone secretagogue pharmacology, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Single-arm open-label study
- Masking
- None
- Phase
- Not applicable
- Randomised participants
- not recorded by the Institute
- Duration of the primary analysis period
- Months
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Induction of ovulation or spermatogenesis by pulsatile administration in hypogonadotrophic hypogonadism
§1.4Principal result
Effective when delivered by pump at a physiological pulse frequency. Non-pulsatile administration downregulates the receptor, which is the pharmacological reason the Institute grades unregulated intermittent use very low certainty.
§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. |