Endometriosis related pain
Conditions
Brief summary
1. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst NMPP NRS score, without increase in opioid rescue medication use, during non-menstrual days, from baseline to the fourth month of treatment.
Detailed description
1. Change in mean worst NMPP NRS score from baseline to the fourth month of treatment, 2. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst DYS NRS score, without increase in rescue medication use, during menstrual bleeding days, from baseline to the fourth month of treatment., 3. Change in mean worst DYS NRS score from baseline to the fourth month of treatment, 4. Change in EHP-30 score from Visit 3 to Visit 7., 5. Change in EHP-30 sexual intercourse subscale score from Visit 3 to Visit 7., 6. Change in mean daily opioid rescue medication use for NMPP from baseline to the fourth month of treatment., 7. Change in mean daily opioid rescue medication use for DYS from baseline to the fourth month of treatment., 8. AEs., 9. Safety laboratory variables (clinical chemistry, hematology, and urinalysis).
Interventions
DRUGVipoglanstat
DRUGThe placebo formulation for GS-248 is formulated in a capsule without the active
ingredient. Both vipoglanstat capsules and placebo are identical capsules.
Sponsors
Gesynta Pharma AB
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst NMPP NRS score, without increase in opioid rescue medication use, during non-menstrual days, from baseline to the fourth month of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in mean worst NMPP NRS score from baseline to the fourth month of treatment, 2. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst DYS NRS score, without increase in rescue medication use, during menstrual bleeding days, from baseline to the fourth month of treatment., 3. Change in mean worst DYS NRS score from baseline to the fourth month of treatment, 4. Change in EHP-30 score from Visit 3 to Visit 7., 5. Change in EHP-30 sexual intercourse subscale score from Visit 3 to Visit 7., 6. Change in mean daily opioid rescue medication use for NMPP from baseline to the fourth month of treatment., 7. Change in mean daily opioid rescue medication use for DYS from baseline to the fourth month of treatment., 8. AEs., 9. Safety laboratory variables (clinical chemistry, hematology, and urinalysis). | — |
Countries
Bulgaria, Czechia, Hungary, Italy, Poland
Outcome results
None listed