Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants

Phase 1 Completed 48 enrolled Myovant Sciences GmbH

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2016-06-16
Primary completion: 2016-09-21
Completion: 2016-09-21

Publications

Lukes A, Migoya E, Johnson B, Lee TY, Li Y, Arjona Ferreira JC. A Randomized Open-Label Study of Relugolix Alone or Relugolix Combination Therapy in Premenopausal Women. Clin Pharmacokinet. 2023 Aug;62(8):1169-1182. doi: 10.1007/s40262-023-01269-9. Epub 2023 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	1 mg	Oral
Subject	Norethindrone	Unknown	0.5 mg	Oral
Subject	Relugolix	Small molecule	40 mg	Oral

Indications

No indication recorded.