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
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
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).
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).
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