RecruitingPHASE2INTERVENTIONAL

A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis

This research study is looking into a new medication called Vipoglanstat for women who suffer from endometriosis. Endometriosis can cause a lot of different pains, and this study is specifically focusing on ongoing pelvic pain that happens even when you're not having your period. The main goal is to find out if Vipoglanstat is effective at reducing this type of pain and how safe it is to use. Some participants will receive the new medicine, while others will receive a 'placebo' – a dummy pill that looks the same but contains no active medicine. This allows researchers to compare the effects and see if Vipoglanstat truly makes a difference. The study is for women aged 18 to 44 who have a confirmed diagnosis of endometriosis and experience significant non-period pelvic pain.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Gesynta Pharma AB

Enrolment target

190

Start

15 Oct 2025

Estimated completion

01 Jun 2027

Endometriosis

What is this study about?

This study is about a condition called endometriosis, which can cause pain in many women. We are testing a new medicine called Vipoglanstat to see if it can help women aged 18 to 44 who have endometriosis and experience ongoing pelvic pain that isn't connected to their menstrual period. This type of pain can really affect daily life, and we are hoping this new medication might offer a way to make it better.

The main aim of the study is to check two things: first, if Vipoglanstat actually reduces this specific type of pelvic pain, and second, if it's safe for women to take. To do this, some women in the study will be given Vipoglanstat, while others will be given a 'placebo.' A placebo is a pill that looks exactly like the study medicine but doesn't contain any active drug. This is a standard way to test new medicines, as it helps us understand if any improvements are genuinely due to the new drug or other factors.

Finding new and effective treatments for endometriosis pain is very important, as it can be a challenging condition to manage. This study takes us one step closer to potentially providing more options for women experiencing this pain.

Key takeaways

This study is testing a new medicine for ongoing pelvic pain in women with endometriosis.
It aims to see if Vipoglanstat is safe and effectively reduces pain not linked to periods.
Participants will receive either the new medicine or a dummy pill (placebo).
Close medical supervision and regular check-ups are part of taking part.
You can stop participating in the study at any time.
The study is for premenopausal women aged 18-44 with confirmed endometriosis.

Who may be eligible?

This study is for women who are between 18 and 44 years old. To take part, you must have been diagnosed with endometriosis within the last 10 years. This diagnosis should have been confirmed either by surgery (where doctors looked inside or took a tiny sample) or by imaging scans like a special ultrasound or MRI that showed endometriosis.

Crucially, you must also experience ongoing pelvic pain that is not related to your period – doctors call this non-menstrual pelvic pain (NMPP) – and it needs to be affecting your daily life. Your pain levels during non-period days in the month before starting the study should be at least moderate, severe, or very severe.

There are also some reasons why you might not be able to join. For example, if your pelvic pain is mainly caused by something other than endometriosis, such as a bladder issue or a different kind of infection, then this study might not be suitable for you. Also, if you've had more than two operations for your endometriosis, you wouldn't be able to participate in this particular study.

Quick self-check

Are you a woman between 18 and 44 years old?
Have you been diagnosed with endometriosis in the last 10 years by surgery or imaging?
Do you experience significant pelvic pain that is NOT during your period?
Is your non-period pelvic pain at least moderate, severe, or very severe?
Have you had two or fewer surgeries for endometriosis?
Is your pelvic pain primarily due to endometriosis, and not other conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll have several visits to the clinic over a period of time. During these visits, doctors and nurses will ask you questions about your pain and how you're feeling. You'll also have physical examinations, and they might take blood samples to check your health and how the medicine is affecting you.

You will be given either the new study medicine, Vipoglanstat, or a placebo (a dummy pill) to take regularly, as instructed by the study team. You won't know which one you're getting, and neither will the study doctors, which helps make the results fair. You'll keep a record of your symptoms and pain levels at home. There will also be follow-up appointments after you stop taking the medication to ensure you are well. The total duration of your involvement in the study will be explained in detail by the study team if you express interest.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new medicine, Vipoglanstat, helps reduce your endometriosis-related pain. You will also be closely monitored by medical professionals throughout the study. However, like all medicines, Vipoglanstat could have side effects, which the study team will discuss with you in detail. There's also the chance that you might receive the placebo and not the active drug. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual healthcare.

Locations (41)

MHAT Puls AD
Blagoevgrad, Bulgaria· Recruiting
Lyulin Hospital
Sofia, Bulgaria· Recruiting
FemiClinic
Sofia, Bulgaria· Recruiting
Gynekologie MEDA s.r.o
Brno, Czechia· Recruiting
Fakultni nemocnice Brno
Brno, Czechia· Recruiting
NEUMED Gynekologicka Ambulance s.r.o.
Olomouc, Czechia· Recruiting
Gyncare MUDr. Michael Svec s.r.o.
Pilsen, Czechia· Recruiting
STELLA-GYN, s.r.o.
Vodňany, Czechia· Recruiting
MedEnd
Budapest, Hungary· Recruiting
Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika
Budapest, Hungary· Recruiting
Robert Karoly Private Hospital Tritonlife Medical Center
Budapest, Hungary· Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary· Recruiting

+29 more sites — see the official record for the full list.

Common questions

What is Vipoglanstat?

Vipoglanstat is a new medicine being tested to see if it can help women with endometriosis-related pelvic pain that occurs outside of their period.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It's used in studies to compare against the new drug.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know whether you are receiving Vipoglanstat or the placebo. This is to ensure the study results are as fair and accurate as possible.

How long will the study last for me?

The study team will explain the full expected duration of your participation, including how long you'll take the medicine and for follow-up appointments.

What kind of pain is this study looking at?

This study is specifically looking at ongoing pelvic pain that women with endometriosis experience even when they are not having their period.

How to find out more

CMO VP Clinical Development

ctg@gesynta.se +46 762 788 389 Official trial record

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