Other: Placebo for Elagolix / Tablet
- participant has chronic pelvic pain that is not caused by endometriosis, that requires
chronic analgesic therapy, which would interfere with the assessment of
- participant is using any systemic corticosteroids for over 14 days within 3 months
prior to screening or is likely to require treatment with systemic corticosteroids
during the course of the study. over-the-counter and prescription topical, inhaled or
intranasal corticosteroids are allowed.
- participant has a history of any major depression or post-traumatic stress disorder
(ptsd) within 2 years of the screening visit or other major psychiatric disorder at
- participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on
the suicidal ideation portion of the columbia-suicide severity rating scale (c-ssrs)
within the last 1 year at screening or prior to randomization on day 1.
- participant has any history of osteoporosis or other metabolic bone disease or any
condition that would interfere with obtaining adequate dual energy x-ray
absorptiometry (dxa) measurements
- screening dxa results of the lumbar spine (l1-l4), femoral neck or total hip bone
mineral density (bmd) corresponding to less than 2.0 or more standard deviations below
- participant has either
1. a newly diagnosed, clinically significant medical condition that requires
therapeutic intervention (e.g., new onset hypertension), that has not been
stabilized 30 days prior to randomization on day 1 or
2. a clinically significant medical condition that is anticipated to require
intervention during the course of study participation (e.g., anticipated major
elective surgery) or
3. an unstable medical condition that makes the subject an unsuitable candidate for
the study in the opinion of the investigator, (including, but not limited to,
uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring
anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease,
hyperprolactinemia, clinically significant infection or injury).
- participant has any conditions contraindicated with use of e2/neta.
As you embark on your clinical trial journey, you may be asking: What happens before the drug gets tested in humans? What is a clinical trial? How come some clinical trials have few participants and some have hundreds or...
AMY ROCHFORD - DEC 27, 2018
Clinical trials is a term that many people have heard, but not enough seem to know about. Conducted to collect data about the efficiency and safety of a potential new treatment option, clinical trials are multi-level processes...
CLINICAL TRIALS - NOV 20, 2018
I have always been someone that loves to volunteer and help the local community. I have participated in food drives, given back to the local animal shelter and volunteered at my local ambulance corp. Volunteers are apart of our everyday life, but they seem to be somewhat easily forgotten about. Think about it. You don’t often think about an EMT or volunteer firefighter...
FRANCESCA DOMINIANNI - JUNE 5, 2019
So you call an Uber, you see your driver has a low rating, do you really want to get in the car or are you now feeling skeptical? Or picture this- you are going on a weekend trip with your friends you haven’t seen in years and you want to pick the best restaurants in the area...
FRANCESCA DOMINIANNI - APR 19, 2019
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.