M14-702 - A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain
Study of Elagolix in Combination with Estradiol/Norethindrone Acetate in Women with Moderate to Severe Endometriosis-Associated Pain
Sponsor: AbbVie
Enrolling: Female Patients Only
IRB Number: AAAR4934
U.S. Govt. ID: NCT02654054
Contact: Nisha Philip: 212-305-4973 / np2173@cumc.columbia.edu
Additional Study Information: This research study involves the use of an investigational drug (a drug that is not approved by the FDA) in premenopausal woman with moderate to severe pain associated with endometriosis. In addition to the investigational drug, you may also receive a small amount of estrogen/progestin medication to decrease some of the side effects from the investigational drug, called add-back therapy. The add-back therapy is being studied with the investigational drug to see if it will reduce the occurrence of symptoms associated with low estradiol levels such as hot flashes, and to prevent potential bone loss which may occur in women who take the investigational drug. Therefore, the use of the add-back therapy is investigational (experimental) for the purposes of this study.
This study is closed
Investigator
Jin Hee Kim, MD
Do You Qualify?
1)Are you premenopausal female between 18 and 49 years of age? Yes No
Do you have documentation of a surgical diagnosis of endometriosis within 10 years? (laparotomy or laparoscopic diagnosis) Yes No
Are you willing to use two forms of non-hormonal contraception (dual contraception) during the duration of the study? Yes No
Are you willing to complete electronic diary entries and visit the study site every month or every other month for first 12 mos? Yes No
Are you willing to use only pain medications permitted by the protocol? Yes No
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You may be eligible for this study

Place Holder




For more information, please contact:
Nisha Philip
np2173@cumc.columbia.edu
212-305-4973