Investigating the effects of the hormone kisspeptin on human brain activity
| ISRCTN | ISRCTN17271094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17271094 |
| IRAS number | 232585 |
| Secondary identifying numbers | IRAS 232585 |
- Submission date
- 28/10/2020
- Registration date
- 29/10/2020
- Last edited
- 06/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Hypoactive Sexual Desire Disorder (HSDD) is characterised by a lack or absence of sexual fantasies and desire for sexual activity. Studies estimate that in the UK HSDD affects 17-40% of men and women, making it one of the most common sexual health complaints. HSDD can result in devastating distress, interpersonal difficulties and detrimental effects on a person's physical and mental wellbeing. Importantly, kisspeptin is an essential reproductive hormone with established roles in controlling human sexual and emotional brain activity, therefore it may have a vital role in HSDD.
Who can participate?
We are looking for men and women who are concerned by low sexual desire and who are aged >18 years, heterosexual, right-handed and in a relationship for at least 6-months. Interested men and women who meet these criteria will be asked to complete a three-stage recruitment process (i. self-reported questionnaire, ii. telephone screening, iii. face-to-face appointment) to confirm eligibility.
What does the study involve?
The study consists of an initial screening visit followed by 2 weekday 4-hour visits. You will receive an injection of a natural and safe hormone (called Kisspeptin), give blood samples, answer some questionnaires and have an MRI scan with physiological monitoring (no radiation).
What are the possible benefits and risks of participating?
Despite its significant burden, medical and psychological treatments have shown only modest benefit. This indicates a need to better understand the underlying sexual and emotional brain activity in HSDD (in order to help develop more effective treatments), which this study will help address. Whilst kisspeptin is a naturally occurring hormone, which has been given safely to > 500 men and women without side effects (by our groups and others), a team of senior doctors will supervise visits with appropriate safety monitoring.
Where is the study run from?
The initial screening visit is held at Charing Cross Hospital (Hammersmith, London), followed by two study visits at Hammersmith Hospital (White City, London) (UK)
When is the study starting and how long is it expected to run for?
June 2017 to December 2022
Who is funding the study?
1. Medical Research Council (UK)
2. NIHR Clinical Research Facility (UK)
3. NIHR Biomedical Research Centre at Imperial College Healthcare NHS Trust (UK)
Who is the main contact?
Professor Waljit Dhillo. The team can be contacted on Imperial.MaleHSDD@nhs.net (male enquiries) and Imperial.FemaleHSDD@nhs.net (female enquiries)
Contact information
Scientific
6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
 ORCID ID |
0000-0001-5950-4316 |
|---|---|
| Phone | +44 (0)207 594 3487 |
| w.dhillo@imperial.ac.uk |
Public
6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
| ORCID ID |
0000-0002-8937-6463 |
|---|---|
| Phone | +44 (0)207 594 3487 |
| e.mills@imperial.ac.uk |
Study information
| Study design | Randomized double-blinded two-way crossover placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | https://www.imperialhsdd.com/ |
| Scientific title | Physiological studies to investigate the effects of kisspeptin on human brain processing |
| Study hypothesis | Kisspeptin modulates brain activity and related behaviours in men and women with low sexual desire via key limbic brain regions. |
| Ethics approval(s) | Approved 12/10/2017, London Riverside Research Ethics Committee (Chelsea & Westminster Hospital, 369 Fulham Road, London, SW10 9NH, United Kingdom; +44 (0)20 7104 8112; riverside.rec@hra.nhs.uk) ref: 17/LO/1504. |
| Condition | Investigation of brain processing in Hypoactive Sexual Desire Disorder |
| Intervention | Randomised, double-blinded, two-way crossover study comparing the effects of a 75-minute intravenous infusion of kisspeptin at 1 nmol/kg/hour versus vehicle (rate-matched intravenous infusion of Gelofusin) on sexual and emotional brain processing (as determined using functional MRI [fMRI]) in men and women with Hypoactive Sexual Desire Disorder. The order of the infusions will be randomized (using www.randomizer.org) and participants will be blinded to the identity of the infusions. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Kisspeptin |
| Primary outcome measure | Sexual and emotional brain processing during validated fMRI tasks (such as male/female facial images and erotic videos), as determined by the change in fMRI blood oxygen level dependent (BOLD) activity measured once in each infusion condition |
| Secondary outcome measures | Measured during intravenous infusion of kisspeptin or vehicle: 1. Hormone and biochemical concentrations, including levels of luteinising hormone, follicle-stimulating hormone, kisspeptin, oestradiol, testosterone, measured every 15-minutes using a blood sample 2. Psychometric measure of motivation determined using the Behavioral Inhibition/Activation System Scale 3. Psychometric measure of sexual arousal and desire determined using the Sexual Arousal & Desire Inventory 4. Psychometric measure of mood determined using the Positive and Negative Affect Schedule 5. Psychometric measure of anxiety and attention determined using the State-Trait Anxiety Inventory and D2 Test of Attention 6. Physical measures of sexual arousal and safety, including blood pressure (sphygmomanometer) and heart rate (pulse oximeter) |
| Overall study start date | 01/06/2017 |
| Overall study end date | 01/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 31 men and up to 31 women are required. To allow for drop-out and exclusion rate, up to 35 men and women will be recruited. |
| Total final enrolment | 64 |
| Participant inclusion criteria | 1. Aged 18 – 70 years (men) 2. Aged >18 years and pre-menopausal (women) 3. Right handed 4. Non-smoker 5. Heterosexual orientation 6. Low sexual desire, meeting the DSM-5 criteria for Hypoactive Sexual Desire Disorder 7. Free of current or past physical or psychiatric illness 8. Naive to psychoactive substances, prescribed or illicit, for a minimum of 6 months prior to screening. 9. Normal or corrected-to-normal vision. 10. Absence of a history of sexual aggression/abuse/phobia or psychotherapy/counselling |
| Participant exclusion criteria | 1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the participant 2. Medical or psychological conditions that would impair their ability to participate reliably in the study or give informed consent 3. Pregnancy and/or breastfeeding 4. Post-menopausal (female) 5. Any implanted material in the body that would preclude magnetic resonance imaging (MRI) for safety reasons 6. Inability to tolerate MRI scanning 7. Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study 8. History of hypersensitivity to any of the components administered 9. Treatment with an investigational drug within the preceding two months 10. Those who have or intend to donate blood or blood products within three months before or following study completion 11. A history of major haematological, renal, thyroid or hepatic abnormalities or significant cardiovascular disease 12. A history of cancer |
| Recruitment start date | 04/01/2021 |
| Recruitment end date | 01/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Du Cane Road
London
W12 0NN
United Kingdom
Sponsor information
University/education
Exhibition Rd
South Kensington
London
SW7 2BU
England
United Kingdom
| Phone | +44 (0)20 7589 5111 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | https://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Imperial BRC, Imperial Biomedical Research Centre, BRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal and presentation at national/international scientific conferences. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/10/2022 | 27/10/2022 | Yes | No | |
| Results article | 01/02/2023 | 06/02/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/02/2023: Publication reference added.
27/10/2022: Publication reference added.
08/08/2022: The recruitment start date has been changed from 10/01/2020 to 04/01/2021.
15/02/2022: The total final enrolment was added.
29/10/2020: Trial’s existence confirmed by London Riverside Research Ethics Committee.
