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A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Documented Endometriosis and Associated Moderate to Severe Pain
18 month trial of elagolix and combined oral contraceptives for women with moderate to severe endometriosis related pain
Subjects will have a screening period of approximately 45 days. If eligible, there will be a 3 month double blind placebo controlled treatment period followed by an open label period of 15 months where all subjects will receive the study medication. Total treatment period is 18 months followed by a one month follow up.Onsite visits are once a month during screening and up until Month 3 when onsite visits will be every 3 months through Month 18.Tests include blood draws at each onsite visit, one ultrasound, an EKG, and 4 DXA scans.
$1475.00
Yes
Amyee McMonagle - at amcmonagle@pennstatehealth.psu.edu or 717-531-4484
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
Female
18 year(s) or older
NCT04333576
STUDY00015216
Inclusion Criteria:
premenopausal females aged 18-49diagnosed with endometriosis with moderate to severe pain
regular menstrual cycles
willing to use non hormonal contraception throughout the study
Exclusion Criteria:
currently pregnant, breastfeeding or planning a pregnancy in the next 18 monthsosteoperosis or other chronic bone disease
other active chronic pain not related to endometriosis
history of hysterectomy or removal of both ovaries
current or former nicotine user if over age 33
Women's Health