Endometriosis
Conditions
Keywords
Non-menstrual pelvic pain, Dysmenorrhea, Pelvic pain
Brief summary
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Interventions
DRUGVipoglanstat
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.
Sponsors
Gesynta Pharma AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment | Baseline to 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment | Baseline to 4 months | — |
| Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment | Baseline to 4 months | — |
| Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment | Baseline to 4 months | — |
| Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment | Baseline to 4 months | — |
| Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment | Baseline to 4 months | — |
| Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment | Baseline to 4 months | — |
| Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment | Baseline to 4 months | — |
| Number of Participants with Adverse Events | Up to 10 months | Any clinically significant changes in laboratory variables, including clinical chemistry, hematology, and urinalysis will be reported as adverse events. |
Countries
Bulgaria, Czechia, Hungary, Italy, Poland, Romania, United Kingdom
Contacts
CONTACTCMO VP Clinical Development
Outcome results
None listed