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Document set current to 30 July 2026
Indication assessment · §3

Hypoactive sexual desire and erectile dysfunction — trial records

Trial records in the Institute's register bearing on hypoactive sexual desire and erectile dysfunction.

Document identifier
CEI-IN-25/3
Series
Indication assessment
Version
1.1
Published
31 Aug 2025
Last reviewed
31 Aug 2025
Next review
31 Aug 2027
Identifier
10.71829/cei.ind.25
Certainty
Not rated
Cycle
2025 Q3
ICD-11
HA00
Category
Neuropsychiatric

§3Trials in this indication

16 trial records in the Institute's register bear on this indication, of which 3 are published trials.

Table 2. Trial records bearing on hypoactive sexual desire and erectile dysfunction.

RecordCompoundPhaseDesignRandomisedYear
RECONNECT-301PT-141 (bremelanotide)Phase 3Randomised, double-blind, placebo-controlled6262019
RECONNECT-302PT-141 (bremelanotide)Phase 3Randomised, double-blind, placebo-controlled6302019
KISS-PH2-HSDDKisspeptin-10Phase 2Randomised crossover322017
RECONNECT-301-BODY-COMPprogramme recordPT-141 (bremelanotide)Phase 3Randomised, double-blind, placebo-controlled2019
RECONNECT-302-DDIprogramme recordPT-141 (bremelanotide)Phase 1Randomised crossover2019
KISS-PH2-HSDD-BIOMARKERprogramme recordKisspeptin-10Phase 2Randomised, double-blind, placebo-controlled2017
RECONNECT-301-REGIONAL-JPprogramme recordPT-141 (bremelanotide)Phase 3Randomised, double-blind, placebo-controlled2019
RECONNECT-302-HEPATIC-IMPprogramme recordPT-141 (bremelanotide)Phase 1Phase 1 ascending dose2019
KISS-PH2-HSDD-ADHERENCEprogramme recordKisspeptin-10Phase 2Observational2017
RECONNECT-301-REGIONAL-CNprogramme recordPT-141 (bremelanotide)Phase 3Randomised, double-blind, placebo-controlled2019
RECONNECT-302-RENAL-IMPprogramme recordPT-141 (bremelanotide)Phase 1Phase 1 ascending dose2019
KISS-PH2-HSDD-OLEprogramme recordKisspeptin-10Phase 2Single-arm open-label2017
RECONNECT-301-QOLprogramme recordPT-141 (bremelanotide)Phase 3Randomised, double-blind, placebo-controlled2019
RECONNECT-302-PKprogramme recordPT-141 (bremelanotide)Phase 1Phase 1 ascending dose2019
KISS-PH2-HSDD-ELDERLYprogramme recordKisspeptin-10Phase 2Randomised, double-blind, placebo-controlled2017
RECONNECT-301-ADHERENCEprogramme recordPT-141 (bremelanotide)Phase 3Observational2019
This facet in the trial register.

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.

  1. 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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