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

  • STATUS
    Recruiting
  • End date
    Apr 4, 2026
  • participants needed
    800
  • sponsor
    AbbVie
Updated on 17 January 2021
Investigator
AbbVie_Call Center
Primary Contact
Continental Clinical Solutions /ID# 217053 (7.6 mi away) Contact
+154 other location
dysmenorrhea
endometriosis
combined oral contraceptives
elagolix

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.

Details
Treatment Elagolix, Placebo for Elagolix, Combined Oral Contraceptive (COC), Placebo for COC
Clinical Study IdentifierNCT04333576
SponsorAbbVie
Last Modified on17 January 2021

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 49 yrs?
Are you female?
Do you have any of these conditions: Endometriosis or Gynecological Infections or Female Genital Diseases?
Do you have any of these conditions: Female Genital Diseases or Gynecological Infections or Endometriosis?
Do you have any of these conditions: Gynecological Infections or Endometriosis or Female Genital Diseases?
Do you have any of these conditions: Female Genital Diseases or Gynecological Infections or Endometriosis?
Do you have any of these conditions: Endometriosis or Gynecological Infections or Female Genital Diseases?
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
Clear my responses

How to participate?

Step 1 Connect with a site
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.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

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

Learn more
Step 3 Enroll in the clinical study

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.

Learn more
Step 4 Get your study results

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet