Elagolix in the Treatment of Endometriosis-Associated Pain (2)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain
IRAS ID
136856
Contact name
Nicholas Raine-Fenning
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2011-004295-11
Research summary
This is a research study looking at the safety and effectiveness of an investigational drug called elagolix, in subjects with moderate to severe pain associated with endometriosis. Women between 18 and 49 years may be eligible to take part.
Elagolix is very similar to a natural hormone called gonadotropin-releasing hormone (GnRH) that is made by brain cells. Elagolix partially blocks the production of oestrogen in the ovaries. Because of this, elagolix is being tested for the treatment of the symptoms of endometriosis, as it is a condition which is very much influenced by oestrogen levels.
Participation in this study lasts up to approximately 20 months and includes approximately 14 study visits to the research centre and 7 study telephone contacts. Participation could be up to 2 to 12 months longer for women taking an exclusionary medication and who would have to stop taking it in order for the effects of this medication to leave their body before they begin taking the study drug.
Participants will be randomly assigned by chance (like the flip of a coin) to receive either elagolix or placebo (an inactive substance). They will have a 57% chance (4 in 7) of receiving elagolix and a 43% chance (3 in 7) of receiving placebo. This is a double-blind study, which means neither they nor the study doctor will know to which active dose they are assigned. In case of an emergency; however, the study doctor can get this information.
There are a number of activities, tests and evaluations at visits. Participants will also be given an electronic device to record symptoms at home.
The study is being done in approximately 220 research centres in the US and other countries, including hospitals in the UK.REC name
Wales REC 3
REC reference
13/WA/0269
Date of REC Opinion
21 Oct 2013
REC opinion
Further Information Favourable Opinion