NCT07260669 A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
| NCT ID | NCT07260669 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gesynta Pharma AB |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 190 participants in total. It began in 2025-10-15 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Eligibility Criteria
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 biopsy 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: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07260669 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07260669 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07260669 currently recruiting?
Yes, NCT07260669 is actively recruiting participants. Contact the research team at ctg@gesynta.se for enrollment information.
Where is the NCT07260669 trial being conducted?
This trial is being conducted at Blagoevgrad, Bulgaria, Sofia, Bulgaria, Sofia, Bulgaria, Brno, Czechia and 11 additional locations.
Who is sponsoring the NCT07260669 clinical trial?
NCT07260669 is sponsored by Gesynta Pharma AB. The trial plans to enroll 190 participants.