ClinicalTrials.gg
Active, not recruitingNCT07260669NOVAUpdated Oct 20, 2026

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

A Phase 2 interventional study of Vipoglanstat and Placebo in Endometriosis, sponsored by Gesynta Pharma AB. Active, not recruiting at 44 sites in 7 countries. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Gesynta Pharma AB · Phase 2, Interventional, and Treatment

Updated Oct 20, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
213
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in Endometriosis with a site in Poland — 3 open to participants now, 4 under way, none of them phase 3. Endometriosis · Poland.

Enrollment
13th of 27
213 · median 187
Started
2025
with 1 other
Phase 2
14 of 29
none open now
Registered
28th of 29
by date
Lead sponsor
1 of 29
Gesynta Pharma AB

Among the 29 studies in Endometriosis with a site in Poland, this one is the 13th largest by enrollment of the 27 interventional ones, is one of 2 that started in 2025, is one of 14 in phase 2, and was the 28th registered.

By phase

29 studies; the count open now beside each. This study's row is marked.

Phase 2this study14 · 0 open
No phase8 · 3 open
Phase 35 · 0 open
Observational2 · 0 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2025.

Size and results

Median enrollment 187 across the 27 interventional studies, 330 across the 2 observational. Of the 22 that completed or were terminated, 11 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 29 studies in Endometriosis with a site in Poland, or all of them as a file.
02

Study summary

The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).

03

Conditions studied

  • Endometriosis

Keywords

  • Non-menstrual pelvic pain
  • Dysmenorrhea
  • Pelvic pain
04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Premenopausal females 18 to \< 45 years of age at the time of Visit 1.
  • Endometriosis diagnosis confirmed and documented within the last 10 years prior to Visit 1 or during Visit based on:

    • Surgical (via direct visualization or verified) or
    • Imaging (ie, endometriotic lesion(s) detected by transvaginal sonography or magnetic resonance imaging [MRI].
  • History of NMPP significantly affecting daily life confirmed at Visit 1.
  • The participant reports moderate, severe, or very severe pain during non-menstrual days in the month prior to Visit 2, based on patient global assessment NMPP.

Exclusion criteria

Exclusion Criteria:

  • Chronic pelvic pain that is not judged to be primarily related to endometriosis (eg, chronic pelvic infection, interstitial cystitis, nerve entrapments or neuropathies, non-endometriosis-related pelvic adhesive disease, persistent symptomatic ovarian cyst [eg, dermoid], posttubal ligation, symptomatic hydrosalpinx, and vaginismus).
  • Has had more than 2 surgical procedures for endometriosis.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
213 participants (actual)

Study arms

  • Experimental
    Dose A Vipoglanstat

    Drug: Vipoglanstat

  • Experimental
    Dose B Vipoglanstat

    Drug: Vipoglanstat

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.

  • DrugPlacebo

    Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

Secondary outcomes

  1. Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

  2. Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

  3. Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

  4. Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment

    Time frame: Baseline to 4 months

  5. Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment

    Time frame: Baseline to 4 months

  6. Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

  7. Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment

    Time frame: Baseline to 4 months

  8. Number of Participants with Adverse Events

    Any clinically significant changes in laboratory variables, including clinical chemistry, hematology, and urinalysis will be reported as adverse events.

    Time frame: Up to 10 months

07

Study locations

44 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.

Of 44 phase 2 interventional studies under Endometriosis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 37. This study's planned 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2025
First posted
Dec 3, 2025
StartActual
Oct 15, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 20, 2026
Enrollment
190 (estimated)→213 (actual)
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Active, not recruiting
    Enrollment 190 (estimated)→213 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07260669
Lead sponsor
Gesynta Pharma AB
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Oct 15, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vipoglanstat

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