AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Genitourinary Syndrome and Female Sexual Dysfunction: Effect of topical glyceryl trinitrate on female genital function in the peri- and postmenopause – a Pilot Study

This study is exploring a new way to help women who are going through or have gone through menopause and are experiencing problems with their intimate health. These common problems, sometimes called Genitourinary Syndrome of Menopause (GSM), can include dryness, discomfort, or pain during sex. The study is testing a special gel containing a medicine called glyceryl trinitrate, which is known to improve blood flow. Researchers want to see if applying this gel could help ease these symptoms by improving how well the genital area functions. This is a very early-stage study, meaning it's one of the first times this treatment is being tested for this purpose in people. The goal is to see if it's safe and if it shows any promise before larger studies are done.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Medical University Of Vienna

Enrolment target

Start

05 Feb 2025

Genitourinary Syndrome of Menopause

What is this study about?

Many women experience changes to their intimate health as they go through menopause, and in the years that follow. These changes are often grouped together as 'Genitourinary Syndrome of Menopause' or GSM. You might notice symptoms like dryness, itching, irritation, discomfort, or even pain during sex. These symptoms happen because the body produces less oestrogen, which can affect the tissues in the genital and urinary areas.

This study is trying a new approach to help with these symptoms. Researchers are looking at whether a gel containing a medicine called glyceryl trinitrate (sometimes shortened to GTN) can make a difference. GTN is a medicine that's often used for other conditions, and it works by widening blood vessels, which improves blood flow. The idea is that improving blood flow to the genital area might help to reduce the dryness and discomfort, making intimate functions more comfortable. It's hoped this could improve overall comfort and intimate health for women with GSM.

This is a 'pilot study', which means it's a small, early-stage study. It's designed to gather initial information about whether this gel is safe to use for this purpose and if it shows any promising signs of working. If this pilot study is successful, it could lead to larger studies in the future, potentially offering a new treatment option for women affected by these common menopausal symptoms.

Key takeaways

This study explores a new gel for menopausal intimate discomfort.
It uses glyceryl trinitrate (GTN) to try and improve blood flow.
It's an early-stage 'pilot study' to check safety and initial effectiveness.
It's for women aged 18 and over who have menopausal intimate symptoms.
The aim is to find better ways to manage Genitourinary Syndrome of Menopause (GSM).

Who may be eligible?

This study is looking for women who are at least 18 years old. To take part, you would need to be experiencing symptoms related to Genitourinary Syndrome of Menopause (GSM), which means you have changes and discomfort in your intimate areas due to menopause.

The study is specifically for women, and there's no upper age limit, meaning women of any age above 18 who meet the other criteria can be considered.

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 18 years old or older?
Are you currently experiencing or have you experienced menopausal symptoms affecting your intimate areas (like dryness or discomfort)?
Are you comfortable using a topical gel as directed by the study team?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves isn't available here, but typically, being part of a study like this means you would have several visits to a clinic over a period of time. During these visits, you might have examinations, answer questionnaires about your symptoms, and possibly provide samples. You would be given the gel to use at home, usually applying it for a set period each day. The study team would then monitor how you're getting on with the treatment and check for any effects. There would also be follow-up appointments to see how the treatment has worked and to ensure your safety throughout the study.

Potential risks and benefits

Participating in a study like this may offer potential benefits, such as gaining access to a new treatment before it's widely available, and possibly seeing an improvement in your symptoms if the gel works. However, there are also potential risks; the gel might not improve your symptoms, or you could experience side effects. While the full list of potential side effects isn't provided here, GTN can sometimes cause headaches or dizziness, especially when first used. Regardless of whether you decide to join, you always 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
Austria

Common questions

What is Genitourinary Syndrome of Menopause (GSM)?

GSM refers to common changes in the intimate and urinary areas that many women experience during and after menopause, leading to symptoms like dryness, discomfort, or painful sex.

What is glyceryl trinitrate (GTN)?

GTN is a medicine that helps to widen blood vessels, improving blood flow. It's often used for heart-related conditions, but this study is testing it as a gel for intimate health.

What is a 'pilot study'?

A pilot study is a small, early-stage study designed to see if a new treatment is safe and shows any promise before larger, more extensive studies are conducted.

Will I definitely get the active gel in the study?

This information isn't fully detailed, but in pilot studies, participants are usually given the active treatment to see if it has an effect. Sometimes a 'dummy' treatment (placebo) is also used for comparison.

What would be expected of me if I join?

You would likely have regular clinic visits, use the gel as instructed, and provide feedback on your symptoms and any side effects you experience.