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
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