Gonadorelin — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Growth hormone deficiency and growth-hormone secretagogue pharmacology
Anchor outcome. Peak stimulated growth hormone.
Effect as recorded. A luteinising hormone rise after gonadorelin distinguishes pituitary from hypothalamic causes of hypogonadotropic hypogonadism; diagnostic performance.[1,2]
Certainty. Moderate certainty The diagnostic evidence base is established and underpins the marketing authorisations.
Contributing trials. GNRH-DIAGNOSTIC. Full structured abstracts are published for each.
Full evidence extract for growth hormone deficiency and growth-hormone secretagogue pharmacology · Indication assessment
§3.2Polycystic ovary syndrome
Anchor outcome. Change in body weight.
Effect as recorded. Pulsatile administration by pump induces ovulation in hypothalamic amenorrhoea with reported ovulation rates above 80 % per cycle in selected patients; observational and small controlled series.[2,3]
Certainty. Moderate certainty This application requires a pump delivering pulses every 60 to 90 minutes. It cannot be reproduced by intermittent injection.
Contributing trials. GNRH-PULSATILE-HH. Full structured abstracts are published for each.
Full evidence extract for polycystic ovary syndrome · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 2016;12(3):325–337. doi:10.2217/whe-2016-0018 · PMID 27638896
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