drugset / Trial / NCT01403038
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
RandomizedParallel-groupOpen-labelBasic science
Summary
This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels.
Timeline
- Start
- 2011-06
- Primary completion
- 2012-10
- Completion
- 2012-11
Publications
- Archer DF, Ng J, Chwalisz K, Chiu YL, Feinberg EC, Miller CE, Feldman RA, Klein CE. Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz086. doi: 10.1210/clinem/dgz086.
- Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Activella | Unknown | — | — |
| Subject | Elagolix | Small molecule | 100 mg | Oral |
| Subject | Elagolix | Small molecule | 150 mg | Oral |
| Subject | Elagolix | Small molecule | 200 mg | Oral |
| Subject | Elagolix | Small molecule | 300 mg | Oral |
Indications
No indication recorded.