Role of the melanocortin-4 receptor in hyposexual desire disorder
Research type
Research Study
Full title
Physiological study to determine the role of the melanocortin-4 receptor in brain activity in women with hypoactive sexual desire disorder
IRAS ID
262886
Contact name
Waljit Dhillo
Contact email
Sponsor organisation
Imperial College NHS Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Hypoactive sexual desire disorder (HSDD) is characterised by a loss of sexual desire that is deemed distressing to an individual. Up to 13% of women suffer from this condition, making it one of the most common female sexual health complaints. HSDD can have a significant impact on quality of life. It can cause relationship difficulties, difficulties with conceiving and can have significant psychological consequences. Current therapeutic options are limited by efficacy and side-effects hence there is an unmet need to develop more effective treatments, through a greater understanding of the pathophysiology of the condition.
The melanocortin system, a collection of nerves in the brain, is thought to be involved in modulating sexual behaviour. Bremelanotide (BMT) is an agent that activates this system. This occurs predominantly through its action on the melanocortin-4 receptor (MC4R), a protein that receives signals within this system, and subsequently initiates downstream effects. In previous studies, BMT has been demonstrated to be safe and exerts a significant treatment benefit in women with HSDD. Hence, this drug can be used to investigate the role of the MC4R in sexual behaviour.
This physiological study will investigate brain activation patterns by functional magnetic resonance imaging (fMRI) during visual erotic stimuli in women with HSDD, in response to MC4R activation (by BMT). We will recruit right-handed, premenopausal women ≥18 years of age with HSDD (≥6-months duration). Following a screening visit and obtaining informed consent, all participants will attend for two study visits each, during which they will undergo an fMRI scan while receiving either BMT or placebo. During the scan, participants will be presented with visual erotic stimuli in order to activate the brain, so that BMT’s modulation of the melanocortin system can be measured.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1161
Date of REC Opinion
28 Aug 2019
REC opinion
Further Information Favourable Opinion