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Study · Randomized controlled trial · n = 32 · 2023

3 results

Effects of Kisspeptin on Sexual Brain Processing and Penile Tumescence in Men With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial.

Mills EG, Ertl N, Wall MB, Thurston L, Yang L, Suladze S, Hunjan T, Phylactou M, Patel B, Muzi B, Ettehad D, Bassett PA and 7 more

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Howard J, Rabiner EA, Bech P, Abbara A, Goldmeier D, Comninos AN, Dhillo WS

JAMA network open1 Feb 2023Cited by 24 (Europe PMC)

PMID36735255 (opens in a new tab)PMCIDPMC9898824 (opens in a new tab)DOI10.1001/jamanetworkopen.2022.54313 (opens in a new tab)PepBankPUB-36735255
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Summary

ImportanceThe human physiological sexual response is crucial for reward, satisfaction, and reproduction. Disruption of the associated neurophysiological pathways predisposes to low sexual desire; the most prevalent psychological form is hypoactive sexual desire disorder (HSDD), which affects 8% of men but currently has no effective pharmacological treatment options. The reproductive neuropeptide kisspeptin offers a putative therapeutic target, owing to emerging understanding of its role in reproductive behavior.ObjectiveTo determine the physiological, behavioral, neural, and hormonal effects of kisspeptin administration in men with HSDD.Design, setting, and participantsThis double-blind, 2-way crossover, placebo-controlled randomized clinical trial was performed at a single academic research center in the UK. Eligible participants were right-handed heterosexual men with HSDD. Physiological, behavioral, functional magnetic resonance imaging (fMRI), and hormonal analyses were used to investigate the clinical and mechanistic effects of kisspeptin administration in response to visual sexual stimuli (short and long video tasks). The trial was conducted between January 11 and September 15, 2021, and data analysis was performed between October and November 2021.InterventionsParticipants attended 2 study visits at least 7 days apart, in balanced random order, for intravenous infusion of kisspeptin-54 (1 nmol/kg/h) for 75 minutes or for administration of a rate-matched placebo.Main outcomes and measuresChanges in (1) brain activity on whole-brain analysis, as determined by fMRI blood oxygen level-dependent activity in response to visual sexual stimuli during kisspeptin administration compared with placebo, (2) physiological sexual arousal (penile tumescence), and (3) behavioral measures of sexual desire and arousal.ResultsOf the 37 men randomized, 32 completed the trial. Participants had a mean (SD) age of 37.9 (8.6) years and a mean (SD) body mass index of 24.9 (5.4). On viewing sexual videos, kisspeptin significantly modulated brain activity in key structures of the sexual-processing network on whole-brain analysis compared with placebo (mean absolute change [Cohen d] = 0.81 [95% CI, 0.41-1.21]; P =  .003). Furthermore, improvements in several secondary analyses were observed, including significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; mean difference = 0.28 units [95% CI, 0.04-0.52 units]; P = .02) and behavioral measures of sexual desire-most notably, increased happiness about sex (mean difference = 0.63 points [95% CI, 0.10-1.15 points]; P = .02).Conclusions and relevanceCollectively, this randomized clinical trial provides the first evidence to date showing that kisspeptin administration substantially modulates sexual brain processing in men with HSDD, with associated increases in penile tumescence and behavioral measures of sexual desire and arousal. These data suggest that kisspeptin has potential as the first pharmacological treatment for men with low sexual desire.Trial registrationisrctn.org Identifier: ISRCTN17271094.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In men with hypoactive sexual desire disorder, kisspeptin‑54 significantly increased penile tumescence in response to sexual stimuli compared with placebo.

    In plain wordsIn men with low sexual desire, kisspeptin‑54 raised penile response to sexual stimuli more than placebo did.

    Peptide
    Kisspeptin-54 (metastin)
    Outcome
    IncreasePenile tumescence in response to sexual stimuli
    Study

    n = 32

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1 nmol/kg/h · intravenous infusion · 75 minutesAs given in this study (human).

    Measurements

    mean difference
    0.28 units
    kisspeptin vs placebo
    increase versus placebo, up to
    56%
    penile tumescence

    Source sentences

    Summary
    significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; mean difference = 0.28 units [95% CI, 0.04-0.52 units]; P = .02)
    3 context sentences
    Summary · context
    This double-blind, 2-way crossover, placebo-controlled randomized clinical trial was performed at a single academic research center in the UK.
    Summary · context
    Participants attended 2 study visits at least 7 days apart, in balanced random order, for intravenous infusion of kisspeptin-54 (1 nmol/kg/h) for 75 minutes or for administration of a rate-matched placebo.
    Summary · context
    Of the 37 men randomized, 32 completed the trial.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In men with hypoactive sexual desire disorder, kisspeptin‑54 significantly increased happiness about sex compared with placebo.

    In plain wordsIn men with low sexual desire, kisspeptin‑54 raised happiness about sex more than placebo did.

    Peptide
    Kisspeptin-54 (metastin)
    Outcome
    IncreaseHappiness about sex (behavioral measure of sexual desire)
    Study

    n = 32

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1 nmol/kg/h · intravenous infusion · 75 minutesAs given in this study (human).

    Measurements

    mean difference
    0.63 points
    kisspeptin vs placebo

    Source sentences

    Summary
    behavioral measures of sexual desire-most notably, increased happiness about sex (mean difference = 0.63 points [95% CI, 0.10-1.15 points]; P = .02).
    3 context sentences
    Summary · context
    This double-blind, 2-way crossover, placebo-controlled randomized clinical trial was performed at a single academic research center in the UK.
    Summary · context
    Participants attended 2 study visits at least 7 days apart, in balanced random order, for intravenous infusion of kisspeptin-54 (1 nmol/kg/h) for 75 minutes or for administration of a rate-matched placebo.
    Summary · context
    Of the 37 men randomized, 32 completed the trial.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In men with hypoactive sexual desire disorder, kisspeptin‑54 infusion significantly modulated brain activity in the sexual-processing network compared with placebo.

    In plain wordsIn men with low sexual desire, kisspeptin‑54 changed activity in sexual-processing brain areas more than placebo did.

    Peptide
    Kisspeptin-54 (metastin)
    Outcome
    MixedBrain activity in the sexual-processing network (fMRI)
    Study

    n = 32

    Comparator
    Placebo
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    1 nmol/kg/h · intravenous infusion · 75 minutesAs given in this study (human).

    Measurements

    mean absolute change (Cohen d)
    0.81 d
    kisspeptin vs placebo
    95% CI
    0.41 to 1.21 d
    kisspeptin vs placebo

    Source sentences

    Summary
    On viewing sexual videos, kisspeptin significantly modulated brain activity in key structures of the sexual-processing network on whole-brain analysis compared with placebo (mean absolute change [Cohen d] = 0.81 [95% CI, 0.41-1.21]; P =  .003).
    3 context sentences
    Summary · context
    This double-blind, 2-way crossover, placebo-controlled randomized clinical trial was performed at a single academic research center in the UK.
    Summary · context
    Participants attended 2 study visits at least 7 days apart, in balanced random order, for intravenous infusion of kisspeptin-54 (1 nmol/kg/h) for 75 minutes or for administration of a rate-matched placebo.
    Summary · context
    Of the 37 men randomized, 32 completed the trial.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    13 Oct 2026, 21:44 UTC

    Study results updated

  2. Version 1

    13 Oct 2026, 16:31 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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