Kisspeptin in Postmenopausal Women with Low Sexual Desire
Research type
Research Study
Full title
Effects of Kisspeptin in Postmenopausal Women with Hypoactive Sexual Desire Disorder
IRAS ID
326800
Contact name
Waljit S Dhillo
Contact email
Sponsor organisation
Imperial College Research Governance and Integrity Team
Duration of Study in the UK
3 years, 0 months, 3 days
Research summary
Lay Summary:
: Low sexual desire that causes significant personal distress, known as Hypoactive Sexual Desire Disorder (HSDD), affects many postmenopausal women and can have a major impact on emotional wellbeing, relationships, and overall quality of life. Although treatments are available for some premenopausal women, there are currently few licensed medications for postmenopausal women with HSDD. This highlights an important need to develop new treatment options.Kisspeptin is a naturally occurring hormone that plays an important role in the reproductive system and also influences sexual desire and arousal. Our previous research has shown that kisspeptin can safely enhance brain responses to sexual cues in men and premenopausal women with HSDD. However, its effects in postmenopausal women have not previously been studied.
In this study, postmenopausal women with HSDD attended two study visits and received either kisspeptin or a placebo on separate occasions. During each visit, participants underwent a brain scan while viewing images designed to stimulate brain regions involved in sexual desire and arousal. We also assessed related behavioural responses.
Our findings suggest that kisspeptin can positively influence brain activity involved in sexual desire and improve measures of sexual desire and arousal in postmenopausal women with HSDD. These results support kisspeptin as a potential new treatment for this condition.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Final analyses are ongoing due to the complexity of the fMRI brain data. This section will be updated alongside manuscript preparation for publication.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 01/06/2027
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 01/06/2027
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: Some datasets generated and/or analysed during the present study will not be publicly available but may be obtained from the corresponding authors upon reasonable request and subject to scientific merit. Any shared data will be fully anonymised to protect the privacy and confidentiality of the participants.Hypoactive Sexual Desire Disorder (HSDD) is a highly prevalent condition characterised by dysfunctional brain activation in regions governing sexual responses, causing a persistent deficiency of sexual desire with marked distress. In postmenopausal women, the prevalence of HSDD ranges from 9-26% (depending on the study cohort) with marked emotional and psychological distress, as well as significant decrements in general health status (including mental and physical health). Unlike in premenopausal women where there are two licensed medications (available in the US), there are currently none for postmenopausal women with HSDD, nor are there any in late-stage development. Hence, there is an unmet need to develop more effective treatments, through a greater understanding of the pathophysiology of the condition in this specific participant-cohort.
The reproductive neuropeptide kisspeptin may represent a safe pharmacological option for postmenopausal women with HSDD owing to emerging understanding of its role in regulating reproductive behaviour. Indeed, in previous studies we have shown that intravenous infusion of kisspeptin safely enhances sexual brain processing in both men and premenopausal women with HSDD. However, until now, the neural, physiological, and behavioural effects of kisspeptin in postmenopausal women with HSDD are unknown.
This physiological study will investigate brain activation patterns by functional magnetic resonance imaging (fMRI) during visual erotic stimuli in postmenopausal women with HSDD, in response to kisspeptin. We will recruit women aged ≥40 years old who are postmenopausal, right-handed, heterosexual, with HSDD (≥6-months duration). Following a screening visit and obtaining informed consent, all participants will attend for two study visits each, receiving either kisspeptin or placebo on each visit (cross-over), during which they will undergo an fMRI scan. During the scan, participants will be presented with visual erotic stimuli in order to activate underlying brain activity, so that kisspeptin’s modulation of sexual brain processing and associated physiological and behavioural measures of sexual desire and arousal can be measured.
REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0763
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Favourable Opinion