Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

Study Identifier
M18-969
CT.gov Identifier
NCT04333576
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
Sign up for trial alerts

Study Details

Medical Condition
  • Endometriosis
    • Study Drug
  • Elagolix
  • Placebo
  • Combined Oral Contraceptive
    • Phase
    Phase 3
    Sex
    Female
    Age
    18 - 49 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Documented surgical confirmation of endometriosis and associated moderate to severe pain. * Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study. * Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs).
    Exclusion Criteria:
    * Pregnant or breastfeeding or planning a pregnancy until completion of the study. * Surgical history of hysterectomy or bilateral oophorectomy. * Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening. * Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.

    Protocol Summary

    Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain.

    Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico.

    Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18.

    There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Pinnacle Research Group /ID# 217062
    Anniston, Alabama, United States, 36207
    Status
    Not applicable
    Location
    ACCEL Research Sites /ID# 218044
    Birmingham, Alabama, United States, 35218
    Status
    Not applicable
    Location
    Alabama Clinical Therapeutics /ID# 217166
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    Alabama Clinical Therapeutics /ID# 222301
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503
    Birmingham, Alabama, United States, 35294-7333
    Status
    Not applicable
    Location
    Trinity Research Group /ID# 246932
    Dothan, Alabama, United States, 36301
    Status
    Not applicable
    Showing {first} - {last} of {total} Results