Endometriosis

  • STATUS
    Recruiting
  • End date
    Feb 18, 2024
  • sponsor
    Abbvie
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Updated on 27 June 2022
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dysmenorrhea
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.

Description

Details
Condition Endometriosis
Clinical Study IdentifierTX302523
SponsorAbbvie
Last Modified on27 June 2022

Eligibility

 Yes No Not Sure

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
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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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