PT-141 (bremelanotide) — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Hypoactive sexual desire and erectile dysfunction
Anchor outcome. Female Sexual Function Index desire domain.
Effect as recorded. Change in Female Sexual Function Index desire domain of +0.30 versus +0.06 with placebo, and improvement in the Female Sexual Distress Scale item 13 of −0.73 versus −0.41; FSFI-D difference 0.24 (95 % CI 0.14 to 0.34); FSDS-DAO 13 difference −0.32 (95 % CI −0.44 to −0.20).[1,2]
Certainty. Moderate certainty Two identical phase 3 trials with statistically significant but small effects on validated instruments. The Institute reports the effect size on the original scale precisely because the statistical significance and the clinical magnitude diverge here, and readers should be able to see both.
Contributing trials. RECONNECT-301 · RECONNECT-302. Full structured abstracts are published for each.
Full evidence extract for hypoactive sexual desire and erectile dysfunction · 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.
- 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
- 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
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