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A study testing vipoglanstat for women with moderate to severe endometriosis-related pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves women with endometriosis, a condition where tissue similar to the lining of the womb grows in other places in the body, often causing pain. The study focuses specifically on pain that occurs outside of menstrual periods, which is called non-menstrual pelvic pain. The treatment being tested is called vipoglanstat, also known by its code name GS-248, which comes in capsule form. Some participants will receive vipoglanstat while others will receive placebo. The purpose of this study is to evaluate how well vipoglanstat works in reducing pain related to endometriosis and to assess its safety.

The study will compare two different doses of vipoglanstat with placebo to see which works best. Participants will take the medication by mouth in capsule form. During the study, women will be asked to record their pain levels, particularly focusing on pain during days when they are not menstruating. The study will also look at pain during menstrual bleeding days, which is called dysmenorrhea. Information will be collected about any use of pain relief medications, including opioid medications, which are strong pain relievers. The study will also measure how endometriosis affects quality of life and daily activities using questionnaires.

The treatment period will last for four months, during which participants will attend several visits. Throughout the study, doctors will monitor participants for any side effects and will perform regular safety checks including blood tests and urine tests. The study will track changes in pain levels from the beginning of treatment to the end of the four-month period to determine if vipoglanstat is effective in reducing endometriosis-related pain.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    After joining the study, you will be randomly assigned to one of three treatment groups. You will receive either vipoglanstat at one of two different doses, or a placebo (a capsule that looks identical but contains no active ingredient).

    The study is double-blind, which means neither you nor your doctor will know which treatment you are receiving during the study.

    You will take the assigned medication by mouth in the form of capsules.

  2. Step 2

    Daily medication and pain tracking

    You will take your assigned capsules daily as instructed throughout the treatment period.

    You will be asked to track your pain levels daily using a pain rating scale. This includes recording your worst pain on days when you are not menstruating (non-menstrual pelvic pain) and during your menstrual bleeding days (dysmenorrhea).

    You will record any use of additional pain medication, including opioid rescue medication, which refers to strong pain relievers you may take when needed.

    This daily tracking will help measure how well the treatment is working.

  3. Step 3

    Regular study visits

    You will attend scheduled study visits throughout the treatment period.

    During these visits, your health will be monitored through physical examinations and laboratory tests, including blood tests and urine tests.

    You will complete questionnaires about your quality of life, including the EHP-30, which is a questionnaire specifically designed to assess how endometriosis affects your daily life and well-being.

    One section of the questionnaire will focus on pain during sexual intercourse.

    Any side effects or health changes you experience will be recorded and reviewed.

  4. Step 4

    Fourth month assessment

    At the end of the fourth month of treatment, your pain levels will be compared to your pain levels at the start of the study.

    The main focus will be on whether your non-menstrual pelvic pain has decreased by at least 2 points on the pain scale, or by at least 30%, without needing to increase your use of opioid pain medication.

    Your menstrual pain (dysmenorrhea) will also be assessed in the same way.

    Changes in your quality of life scores and your use of rescue pain medication will be evaluated.

  5. Step 5

    Safety monitoring throughout the study

    Throughout the entire study period, your safety will be closely monitored.

    Any adverse events, which are any unwanted or unexpected health problems that occur during the study, will be recorded and assessed.

    Regular laboratory tests will check your blood cell counts, kidney and liver function, and other health markers.

    All safety information will be reviewed to ensure the treatment is well-tolerated.

Who can join the trial?

5 criteria

  • You must be a premenopausal female, which means you still have regular menstrual periods and have not yet gone through menopause
  • You must be between 18 and 44 years old at the first visit
  • You must have a confirmed diagnosis of endometriosis, which is a condition where tissue similar to the lining of the uterus grows outside the uterus. This diagnosis must have been confirmed within the last 10 years or at the first visit through one of these methods: surgery where the doctor directly saw the tissue or took a sample for testing, or through imaging tests such as transvaginal ultrasound, which is an internal ultrasound examination, or MRI, which is a magnetic resonance imaging scan that creates detailed pictures of the inside of your body
  • You must have a history of non-menstrual pelvic pain, which is pain in the lower belly area that occurs at times other than during your period, and this pain must significantly affect your daily activities
  • You must report that you experienced moderate, severe, or very severe pain on days when you were not having your period during the month before the second visit

Who cannot join the trial?

11 criteria

  • You are a man. This study only includes women.
  • You are under 18 years old. This study is only for adults.
  • You do not have endometriosis-related pain. Endometriosis is a condition where tissue similar to the lining of the womb grows outside the womb, causing pain.
  • You are pregnant or planning to become pregnant during the study period.
  • You are breastfeeding.
  • You have a known allergy or bad reaction to the study medicine or any of its ingredients.
  • You have severe liver or kidney problems that could affect how your body processes the medicine.
  • You have other serious medical conditions that could make it unsafe for you to participate.
  • You are taking certain medicines that could interact badly with the study medicine.
  • You have participated in another clinical trial within the last few weeks or months.
  • You are unable or unwilling to follow the study requirements, such as attending visits or taking the medicine as directed.
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Investigated drugs

  • Vipoglanstat

    is an investigational medication being studied for the treatment of moderate to severe pain related to endometriosis. This medication is being tested to see if it can help reduce pain that women experience due to endometriosis, a condition where tissue similar to the lining of the uterus grows outside the uterus.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of vipoglanstat against no active treatment, helping researchers determine if the medication truly works.

What is already known about the treatment

Vipoglanstat – Vipoglanstat is an investigational medication currently being studied in clinical trials and has not yet been approved for general medical use. It is being tested as a treatment for moderate to severe pain associated with endometriosis, a condition where tissue similar to the uterine lining grows outside the uterus causing significant discomfort. The drug is being evaluated in tablet or capsule form taken by mouth, and researchers are testing two different dose levels to determine which works best while maintaining safety. Vipoglanstat is designed to work at the molecular level by blocking specific enzymes or receptors involved in pain and inflammation pathways related to endometriosis.

Investigated diseases

Endometriosis – Endometriosis is a condition where tissue similar to the lining of the uterus grows outside the uterus, commonly on the ovaries, fallopian tubes, and other pelvic organs. This misplaced tissue continues to act as it normally would during the menstrual cycle, thickening, breaking down, and bleeding with each period. However, because this tissue has no way to exit the body, it becomes trapped and can cause inflammation and the formation of scar tissue. The condition often causes pain, particularly during menstrual periods, but can also result in pain during other times of the month unrelated to menstruation. Pain during sexual intercourse and bowel movements are also common symptoms. Over time, endometriosis can lead to the development of adhesions that bind organs together and affect daily functioning and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522452-16-00Protocol codeGS-248-203Estimated enrolment382 patientsSponsorGesynta Pharma AB

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