Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-25 @ 4:15 PM
NCT ID:
NCT03213457
Pre Assignment Details:
Participants were randomly assigned on Study Day 1 in a 4:1:2 ratio as follows:
* elagolix 200 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) 1 mg/0.5 mg once daily (QD)
* elagolix 200 mg BID
* placebo
Data are presented for the 12-month Placebo-Controlled Treatment Period.
Recruitment Details:
A total of 679 subjects were treated at 137 sites in 2 countries (US \[including Puerto Rico\] and Canada). Of the 679 subjects who were treated on study, 299 subjects discontinued study drug prematurely during the Placebo-Controlled Treatment Period and 240 discontinued study drug prematurely during the Open-Label Treatment Period.
Study:
NCT03213457
Study Brief:
Results Section:
NCT03213457