Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions - SOPKGANI

This research, called SOPKGANI, is exploring a new, short-term treatment for women who have Polycystic Ovary Syndrome (PCOS). PCOS is a common condition that can affect a woman's hormone levels and can cause various symptoms. The study is investigating a specific medicine, called a GnRH-antagonist, to see if it can help reduce certain hormone pulses, called LH pulsatility. By doing this, researchers hope to improve overall hormone balance and how the body functions in women with PCOS. This is an early stage study, meaning it's one of the first times this treatment is being tested in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Centre Hospitalier Universitaire De Lille

Enrolment target

Start

08 Nov 2024

Polycystic ovarian

What is this study about?

This study, known as SOPKGANI, is focusing on women who have Polycystic Ovary Syndrome (PCOS). PCOS is a really common health issue that can affect hormone levels and cause a range of symptoms like irregular periods, acne, and difficulty getting pregnant. Scientists are constantly looking for better ways to manage these symptoms and improve the health of women with PCOS.

The main idea behind this study is to see if a particular type of medicine, called a GnRH-antagonist, can help. This medicine is designed to temporarily lower the 'pulsing' of a hormone called LH (Luteinizing Hormone). Hormones in our bodies often work in pulses, and in PCOS, these pulses can sometimes be out of sync. By carefully adjusting these pulses for a short time, researchers hope to bring other hormones into better balance.

This is a very early stage of research, sometimes called a Phase I study. This means it's one of the first times this treatment approach is being tested in people. The main goal at this stage is to understand how safe the treatment is and how it affects the body's hormones. If it proves to be safe and effective in this initial stage, it might be studied further in the future to see if it can become a helpful new treatment option for women with PCOS.

Key takeaways

Targets women with Polycystic Ovary Syndrome (PCOS).
Investigates a short-term treatment to balance hormones.
Aims to reduce specific hormone pulses (LH pulsatility).
It's an early-stage study (Phase I) looking at safety and effects.
Could help scientists find new ways to manage PCOS symptoms.

Who may be eligible?

To take part in this study, you need to be a woman and at least 18 years old. There isn't an upper age limit mentioned, so older women might also be able to join.

Because this study is specifically for women with Polycystic Ovary Syndrome, you would need to have been diagnosed with this condition by a doctor.

Beyond these basic requirements, there will be other health checks and criteria that the study doctors will go through with you. These are in place to make sure the study is safe for you and that the results are clear and reliable. They will make sure the study is a good fit for your individual health situation.

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 a woman?
Are you at least 18 years old?
Have you been diagnosed with Polycystic Ovary Syndrome (PCOS)?
Are you generally healthy enough to participate in a medical study? (This will be assessed by the study team)

Answer every question to see your result.

What does participation involve?

Information about what taking part involves is not provided in detail here, but typically, joining a study like this means you would have several visits to a clinic or hospital. These visits usually involve health checks, blood tests to measure your hormone levels, and potentially taking the study medication. You'll be closely monitored by the study team to ensure your safety and to track how the treatment is affecting you. There will also be follow-up appointments after you stop taking the medication to see how your body adjusts. The total duration of your involvement could range from weeks to a few months, depending on the study design.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that it might help contribute to better understanding and treatment of PCOS in the future. You might also receive close medical attention and monitoring from specialists. However, there could be side effects from the medication, which would be explained in full before you agree to take part. It's really important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is PCOS?

PCOS, or Polycystic Ovary Syndrome, is a common condition affecting women where hormone levels are out of balance, which can cause irregular periods and other symptoms.

What is LH pulsatility?

LH pulsatility refers to the way Luteinizing Hormone (LH) is released in small bursts or 'pulses' in the body. In PCOS, these pulses can sometimes be irregular.

Is this a new medicine?

The study is looking at a specific medicine (a GnRH-antagonist) that aims to adjust hormone levels. This is an early stage study, so it's one of the first times this specific approach is being tested in people with PCOS.

How long would I have to be in the study?

The information provided doesn't specify the exact duration, but short-term treatments in early studies often involve weeks to a few months of participation.

Will this study cure my PCOS?

This study is an early investigation to see if a treatment can improve hormone function. While it's not designed as a cure, it might help researchers find better ways to manage PCOS in the future.