Effects of Kisspeptin on Reproductive Hormones
Official title: The Physiological Changes in Reproductive Hormones During Sustained Administration of Kisspeptin in Humans.
Run by Imperial College London · NCT02081924 · Data updated 2026-11-12
This study is testing if giving kisspeptin can change hormone levels in people with fertility issues or problems with their hypothalamus.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | April 2, 2014 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT02081924 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18-60 with secondary hypogonadism or healthy participants.
✕Probably not a fit
Patients with severe medical conditions, active psychiatric illnesses, or those currently pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of kisspeptin administration on reproductive hormone levels, specifically Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), testosterone, and oestradiol. Participants will undergo an initial baseline assessment of hormone levels, followed by an infusion of kisspeptin or placebo over a series of menstrual cycles. Blood samples will be collected at regular intervals to monitor hormone changes during the infusion. The study aims to determine how different doses of kisspeptin affect hormone levels in individuals with fertility disorders or hypothalamic dysfunction.
Why it matters
Potential benefit: If successful, this study could provide new insights into treatments for fertility disorders by enhancing our understanding of reproductive hormone regulation.
How similar studies have gone: While the use of kisspeptin in hormone regulation is a relatively novel approach, preliminary studies have shown promising results in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Aged 18-60 years old * Ability to give informed consent * Secondary hypogonadism (or healthy participant) Exclusion criteria: * anaemia * medical problems such as severe heart, kidney or liver disease * blood donation in the last three months or intention to donate blood within 3 months of the end of the study * needle phobia * Poor venous access * Active psychiatric illness * Severe allergies * Impaired ability to provide full consent to take part in the study * Current alcohol or illicit drug dependence * Current pregnancy or breast feeding * Plans to conceive within 3 months of starting the study (barrier contraception must be used during and for 3 months after the end of the study) * Arthritis or any impairment of hand coordination which would preclude using a hormone pump
Where it's running
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Imperial College NHS Healthcare Trust
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Waljit Dhillo, PhD, FRCP — Imperial College London
- Study coordinator: ALi Abbara, PhD MRCP
- Email: ali.abbara@imperial.ac.uk
- Phone: 020 8383 3242
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.