Clinical studies to examine the effects of intranasal kisspeptin delivery on reproductive hormones
| ISRCTN | ISRCTN10095215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10095215 |
| IRAS number | 232585 |
| Secondary identifying numbers | Protocol version 4, IRAS 232585 |
- Submission date
- 08/03/2022
- Registration date
- 09/03/2022
- Last edited
- 28/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims:
Kisspeptin is a hormone which acts as the master regulator of reproductive hormone release in humans. Clinical studies demonstrate that intravenous (into a vein) or subcutaneous (under the skin) kisspeptin administration could be used to treat reproductive disorders. A non-invasive delivery route would be preferable to patients and clinicians. To address this, the aim of this study is to find out whether intranasal administration (snorting) of kisspeptin can stimulate reproductive hormone release in healthy volunteers and patients with reproductive disorders.
Who can participate?
Healthy men and women and patients with reproductive disorders, aged 18 – 70 years
What does the study involve?
Participants will attend at least two study visits at least 1 week apart at the Clinical Research Unit (Charing Cross Hospital, London). At one visit kisspeptin will be self-administered using a nasal spray device and at the other visit a placebo (dummy drug) will be used instead. Blood samples will be collected through a cannula (tube) every 15 minutes for 4 hours to measure reproductive hormone release.
What are the possible benefits and risks of participating?
Kisspeptin is a naturally occurring hormone which has been given to over 500 men and women without complications or side effects. The main benefit will be to help develop a future treatment for patients with reproductive disorders.
When is the study starting and how long is it expected to run for?
June 2017 to April 2024
Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Edouard Mills
imperial.kisspeptin@nhs.net
Contact information
Public
6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)207 594 3487 |
|---|---|
| imperial.kisspeptin@nhs.net |
Principal Investigator
6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)207 594 3487 |
|---|---|
| imperial.kisspeptin@nhs.net |
Study information
| Study design | Randomized placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41319_PIS_27Jan20_V5.pdf |
| Scientific title | Investigating the effects of intranasal kisspeptin administration on reproductive hormone secretion |
| Study hypothesis | Intranasal kisspeptin administration stimulates reproductive hormone secretion in healthy volunteers and patients with common reproductive disorders. |
| Ethics approval(s) | Approved 12/10/2017, London Riverside Research Ethics Committee (Chelsea & Westminster Hospital, 369 Fulham Road, London, SW10 9NH, UK; +44 (0)20 7104 8112; riverside.rec@hra.nhs.uk), REC ref: 17/LO/1504 |
| Condition | Reproductive disorders |
| Intervention | Randomised, placebo-controlled, cross-over study in healthy volunteers (men and women) and patients with common reproductive disorders (including hypothalamic amenorrhoea). Following self-administration of intranasal kisspeptin (dose range 3.2 to 25.6 nmol/kg) or placebo using a nasal spray device, serum reproductive hormones are measured every 15 minutes for 4 hours. Study visits will be at least 1 week apart to ensure washout, with the order of the interventions randomised (using https://www.randomizer.org). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Kisspeptin-54 |
| Primary outcome measure | Blood levels of reproductive hormones (kisspeptin, luteinizing hormone, follicle stimulating hormone, testosterone [men] and oestradiol/progesterone [women]) measured using automated chemiluminescent immunoassays at baseline and every 15 minutes for 4 hours |
| Secondary outcome measures | 1. Safety monitoring: heart rate, blood pressure, and the presence of adverse symptoms measured using automated blood pressure monitor every 15 minutes for 4 hours 2. Behavioural parameters of reproductive behaviour assessed using validated psychometric questionnaires (including the Sexual Arousal and Desire Inventory, Positive and Negative Affect Schedule, and State-Trait-Anxiety-Inventory) at baseline and every hour until 4 hours |
| Overall study start date | 01/06/2017 |
| Overall study end date | 01/04/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | A minimum of 12 healthy volunteers and 6 patients with reproductive disorders |
| Participant inclusion criteria | Healthy volunteers: 1. Aged 18–70 years 2. Non-smokers 3. Free of current or past physical or psychiatric illness 4. Naive to psychoactive substances, prescribed or illicit, for a minimum of 6 months prior to screening. 5. Regular menstrual cycles (women) For patients with common reproductive disorders: 1. Patients diagnosed in accordance with established guidelines (e.g. Endocrine Society guidelines for hypothalamic amenorrhoea) |
| Participant exclusion criteria | 1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products and hormonal therapies, 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. Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study 5. History of hypersensitivity to any of the components administered 6. Treatment with an investigational drug within the preceding 2 months 7. Those who have or intend to donate blood or blood products within three months before or following study completion 8. A history of major haematological, renal, thyroid or hepatic abnormalities or significant cardiovascular disease 9. A history of cancer |
| Recruitment start date | 14/01/2020 |
| Recruitment end date | 01/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Charing Cross Hospital
Fulham Palace Rd
London
W6 8RF
United Kingdom
Sponsor information
University/education
Hammersmith Campus
Du Cane Road
London
W12 0NN
England
United Kingdom
| Phone | +44 (0)20 7589 5111 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | http://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
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Biomedical Research Centre Bristol, National Institute for Health Research Bristol Biomedical Research Centre, NIHR Bristol BRC, Bristol BRC, Bristol Biomedical Research Centre
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | 1. Presentation at national and international scientific conferences 2. Publication in high-impact medical journals |
| IPD sharing plan | Restrictions apply to the availability of some or all data generated or analyzed during this study to preserve patient confidentiality. The team will on request detail the restrictions and any conditions under which access to some data may be provided. Please contact Prof. Waljit Dhillo (w.dhillo@imperial.ac.uk). The data will only become available once the study has been completed and will be at the discretion of the PI. Most data will not be available due to participant confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 5 | 27/01/2020 | 09/03/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
28/07/2023: Participant recruitment for the patient arm of this study commenced on 03/05/2022.
13/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2022 to 01/12/2023.
2. The overall trial end date was changed from 01/04/2023 to 01/04/2024.
3. The intention to publish date was changed from 01/08/2023 to 01/08/2024.
09/03/2022: Trial's existence confirmed by the London Riverside Research Ethics Committee.
