Condition category
Mental and Behavioural Disorders
Date applied
28/10/2020
Date assigned
29/10/2020
Last edited
29/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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)

Trial website

https://www.imperialhsdd.com/

Contact information

Type

Scientific

Primary contact

Prof Waljit Dhillo

ORCID ID

http://orcid.org/0000-0001-5950-4316

Contact details

6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)207 594 3487
w.dhillo@imperial.ac.uk

Type

Public

Additional contact

Dr Edouard Mills

ORCID ID

http://orcid.org/0000-0002-8937-6463

Contact details

6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)207 594 3487
e.mills@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 232585

Study information

Scientific title

Physiological studies to investigate the effects of kisspeptin on human brain processing

Acronym

Study hypothesis

Kisspeptin modulates brain activity and related behaviours in men and women with low sexual desire via key limbic brain regions.

Ethics approval

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.

Study design

Randomized double-blinded two-way crossover placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

https://www.imperialhsdd.com/

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

Phase

Not Applicable

Drug names

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 trial start date

01/06/2017

Overall trial end date

01/12/2022

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

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.

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

10/01/2020

Recruitment end date

01/02/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
Hammersmith Campus Du Cane Road
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Exhibition Rd
South Kensington
London
SW7 2BU
United Kingdom
+44 (0)20 7589 5111
becky.ward@imperial.ac.uk

Sponsor type

University/education

Website

https://www.imperial.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

NIHR Imperial Biomedical Research Centre

Alternative name(s)

Imperial Biomedical Research Centre, NIHR Imperial BRC, BRC

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal and presentation at national/international scientific conferences.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/10/2020: Trial’s existence confirmed by London Riverside Research Ethics Committee.