This was a randomized, open-label, repeat dose study of once daily relugolix alone or relugolix combined with hormonal add-back therapy (combination estradiol/norethindrone acetate) (E2/NETA) to assess safety, including markers of bone resorption, pharmacokinetics (PK), and pharmacodynamics (PD) endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Clinical Study Site
Minneapolis, Minnesota, United States
PK: Area Under The Concentration-Time Curve From Time Zero To Hour 24 (AUC0-24) Of Relugolix, E2, Estrone (El), Ethinylestradiol (EE), NETA
Time frame: Predose and up to 24 hours at Weeks 3 and 6
PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA
Time frame: Predose and up to 24 hours at Weeks 3 and 6
PK: Time To Maximum Concentration (Tmax) Of Relugolix, E2, El, EE, NETA
Time frame: Predose and up to 24 hours at Weeks 3 and 6
Change From Baseline In Serum Follicle Stimulating Hormone (FSH) At Week 6
Time frame: Baseline, Week 6
Change From Baseline In Serum Luteinizing Hormone (LH) At Week 6
Time frame: Baseline, Week 6
Change From Baseline In Serum Progesterone (P) At Week 6
Time frame: Baseline, Week 6
Change From Baseline In Serum E2 And E1 At Week 6
Time frame: Baseline, Week 6
Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6
Time frame: Baseline, Week 6
Incidence Of Treatment-Emergent Adverse Events
Time frame: 8 weeks
Incidence Of Hot Flush
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.