A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids

Updated on 23 November 2020


A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids


The objectives of this study are to assess the safety and efficacy of elagolix (ABT-620) alone and in combination with two (2) different strengths of add-back therapy (Estradiol/Norethindrone Acetate Tablets), versus placebo to reduce heavy menstrual bleeding (HMB) asociated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 18 to 51 years of age.

About the Study

This study is evaluating an investigational oral medication to see if it can lower estrogen levels without menopause-like side effects such as hot flashes and bone loss. Estrogen and progesterone produced in your ovaries influence the growth of fibroids. The investigational medication being studied partially blocks the production of these hormones. Researchers want to find out if lowering hormone levels will shrink the size of fibroids and decrease the amount of blood loss during periods.

No Insurance Required, reimbursement for time and travel may be provided.


To see if you qualify call Mary Jane at 609-895-0735 x137

Condition Uterine Fibroids
Clinical Study IdentifierTX137474
Last Modified on23 November 2020


Yes No Not Sure

Inclusion Criteria

To qualify you must
Be premenopausal, up to 51 years old
Have heavy periods associated with uterine fibroids
Experience monthly periods
You will need to undergo additional tests and procedures to see if you qualify for the study. As a participant, you will be asked to make monthly visits to the study center and monitor the amount of bleeding during your periods
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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