The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Who can participate
Age range18 Years – 44 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment