RecruitingNAINTERVENTIONAL

Reproductive Hormones During Sustained Administration of Kisspeptin

This study wants to learn how a hormone called kisspeptin affects reproductive hormones like LH, FSH, testosterone, and oestradiol in people. We're giving it to volunteers for 8 days each month, across four different menstrual cycles. Each month, participants will receive either a dummy treatment (saline) or one of three different doses of kisspeptin (0.1, 0.3, or 1.0 nmol/kg/hour). We'll be taking regular blood samples to see how these hormone levels change over time. The goal is to understand how sustained use of kisspeptin might influence fertility-related hormones, which could eventually help people with fertility problems or issues with how their brain controls hormones.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

02 Apr 2014

Estimated completion

30 Nov 2027

Fertility Disorders Hypothalamic Dysfunction

What is this study about?

This study is looking at an important hormone called kisspeptin. Our bodies naturally make kisspeptin, and it plays a key role in controlling other hormones that are essential for reproduction and fertility. We want to understand exactly how giving kisspeptin over several days affects the levels of these reproductive hormones in the body.

Specifically, we're interested in Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), testosterone, and oestradiol. These hormones are all vital for healthy reproductive function. By carefully measuring how they change when kisspeptin is given continuously, we hope to learn more about how kisspeptin works. This knowledge could be really helpful in the future for people who have fertility problems or conditions where their brain isn't quite controlling their hormones as it should.

Participants will receive kisspeptin or a dummy treatment for 8 days each month over four months. This will help us see if there's a difference between active treatment and no treatment, and if different amounts of kisspeptin have different effects. We believe this research could pave the way for new ways to help individuals with certain fertility challenges.

Key takeaways

The study explores how kisspeptin affects fertility hormones.
Participants will receive kisspeptin or a dummy treatment via a small pump.
Involves regular blood tests over 8 days during four separate monthly cycles.
Aimed at understanding natural hormone control for potential future fertility treatments.
You can withdraw from the study at any time.
Participation requires being between 18 and 60 years old and meeting certain health criteria.

Who may be eligible?

You might be able to join this study if you are between 18 and 60 years old and are generally healthy, or if you have a specific condition called secondary hypogonadism (which means your body isn't producing enough hormones that control reproduction).

However, there are some reasons why you wouldn't be able to take part. For example, if you have certain health problems like severe heart, kidney, or liver disease, anaemia, or an active mental health condition. You also can't participate if you've recently donated blood or plan to in the next three months.

We also can't include you if you're pregnant, breastfeeding, or planning to get pregnant within three months of starting the study (you'll need to use reliable contraception). Other reasons include a strong fear of needles, difficulty having blood taken, severe allergies, or problems with hand movement that would make it hard to use a small pump.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Do you have good general health, or a diagnosis of secondary hypogonadism?
Are you able to use reliable contraception if you could become pregnant and don't plan to conceive in the next 3 months?
Do you not have severe heart, kidney, or liver disease, or anaemia?
Are you comfortable with needles and having blood taken frequently?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will involve four cycles over different months. In each cycle, here's what to expect:

First, you'll have an initial 'baseline' visit where we'll take blood samples regularly over 8 hours to check your usual hormone levels. After this, on a different day, a small pump will be attached to deliver either a dose of kisspeptin or a dummy treatment (saline) just under your skin. On the first day with the pump, you'll have another 8-hour session of regular blood sampling. You'll then return for short check-ups and a single blood test on day 3 and day 5 of the pump infusion. On day 5, the pump will also be replaced. Finally, on day 8, you'll come back for another 8-hour blood sampling session, and then the pump will be removed.

This whole process (baseline, pump for 8 days, and all the blood tests) will be repeated once during the early part of four separate monthly cycles. In total, you'll have four cycles of treatment, one per month, with breaks in between. The study involves several visits to the research unit and consistent use of a small pump for 8 days during each of the four cycles.

Potential risks and benefits

Taking part in this study could help us learn more about how kisspeptin affects hormones, which might lead to better treatments for fertility problems in the future. As with any medical study, there are potential risks, such as discomfort from blood tests or pump insertion, and possible side effects from the kisspeptin, although those are carefully monitored. You will be fully informed of all known side effects. It's really important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College NHS Healthcare Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is kisspeptin?

Kisspeptin is a natural hormone made by your body that plays a key role in controlling other hormones essential for fertility and reproduction.

What are 'reproductive hormones'?

These are hormones like LH, FSH, testosterone, and oestradiol that are vital for how our reproductive system works, including fertility.

Will I know if I'm getting kisspeptin or a dummy treatment?

No, this is a 'blinded' study, meaning neither you nor the study team will know during the study whether you are receiving kisspeptin or the dummy treatment. This helps ensure unbiased results.

How is the kisspeptin given?

It's given through a small pump that delivers the hormone continuously into the fatty tissue just under your skin, similar to an insulin pump.

How long will I be in the study?

The study involves participation during the early part of four separate monthly cycles, with follow-up appointments within each cycle.

How to find out more

ALi Abbara, PhD MRCP

ali.abbara@imperial.ac.uk 020 8383 3242 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.