drugset / Trial / NCT04614246
Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: * Study duration: 155 up to 285 days * Treatment duration: 84 days * Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo
Timeline
- Start
- 2021-01-29
- Primary completion
- 2022-01-17
- Completion
- 2022-05-03
Publications
- Parke S, Gude K, Roth K, Messina F. Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study. BMC Womens Health. 2024 Jun 19;24(1):353. doi: 10.1186/s12905-024-03188-8.
- Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Elagolix | Small molecule | 150 mg | Oral |
| Subject | eliapixant | Small molecule | 25 mg | Oral |
| Subject | eliapixant | Small molecule | 75 mg | Oral |
| Subject | eliapixant | Small molecule | 150 mg | Oral |