drugset / Trial / NCT01441635
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.
Timeline
- Start
- 2011-09-08
- Primary completion
- 2013-11
- Completion
- 2014-05-17
Publications
- Background Archer DF, Stewart EA, Jain RI, Feldman RA, Lukes AS, North JD, Soliman AM, Gao J, Ng JW, Chwalisz K. Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study. Fertil Steril. 2017 Jul;108(1):152-160.e4. doi: 10.1016/j.fertnstert.2017.05.006. Epub 2017 Jun 1.
- Coyne KS, Soliman AM, Margolis MK, Thompson CL, Chwalisz K. Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire. Curr Med Res Opin. 2017 Feb;33(2):193-200. doi: 10.1080/03007995.2016.1248382. Epub 2016 Nov 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elagolix | Small molecule | 100 mg | — |
| Subject | Elagolix | Small molecule | 200 mg | — |
| Subject | Elagolix | Small molecule | 300 mg | — |
| Subject | Elagolix | Small molecule | 400 mg | — |
| Subject | Elagolix | Small molecule | 600 mg | — |
| Background | Estradiol | Other / unclassified | 0.1 mg | Oral |
| Background | Estradiol | Other / unclassified | 0.5 mg | Oral |
| Background | Estradiol | Other / unclassified | 1 mg | — |
| Background | Progesterone | Other / unclassified | 200 mg | — |