CLINICAL TRIALS PROFILE FOR LINZAGOLIX
✉ Email this page to a colleague
Clinical Trials for Linzagolix
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03961932 ↗ | Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function | Completed | ObsEva SA | Phase 1 | The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired renal function compared to matched control subjects with normal renal function |
| NCT03962049 ↗ | Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function | Completed | ObsEva SA | Phase 1 | The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function |
| NCT03986944 ↗ | A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain | Terminated | ObsEva SA | Phase 3 | The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP). |
| NCT03992846 ↗ | Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain. | Active, not recruiting | ObsEva SA | Phase 3 | The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP). |
| NCT04335591 ↗ | Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6) | Enrolling by invitation | ObsEva SA | Phase 3 | The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis. |
| NCT04372121 ↗ | Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain | Terminated | ObsEva SA | Phase 3 | The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for Linzagolix
Condition Name
Clinical Trial Locations for Linzagolix
Trials by Country
Clinical Trial Progress for Linzagolix
Clinical Trial Phase
Clinical Trial Sponsors for Linzagolix
Sponsor Name
