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Trial record 2 of 7 for:    abbvie | endometriosis | United States
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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

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ClinicalTrials.gov Identifier: NCT04333576
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Endometriosis Drug: Elagolix Drug: Combined Oral Contraceptive (COC) Drug: Placebo for Elagolix Drug: Placebo for COC Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : September 2, 2024
Estimated Study Completion Date : February 23, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Elagolix

Arms and Interventions
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Arm Intervention/treatment
Experimental: Elagolix + Combined Oral Contraceptive (COC)
Participants will receive elagolix in combination with COC for 18 months.
 Drug: Elagolix
Tablet:Oral
Other Names:
  • ABT-620
  • Orilissa

Drug: Combined Oral Contraceptive (COC)
Tablet:Oral

Drug: Combined Oral Contraceptive (COC)
Capsule:Oral
Experimental: Elagolix + Placebo for COC
Participants will receive elagolix in combination with placebo for COC for 3 months followed by elagolix in combination with COC for 15 months.
 Drug: Elagolix
Tablet:Oral
Other Names:
  • ABT-620
  • Orilissa

Drug: Combined Oral Contraceptive (COC)
Tablet:Oral

Drug: Placebo for COC
Capsule:Oral
Placebo Comparator: Placebo for Elagolix + Placebo for COC
Participants will receive placebo for elagolix in combination with placebo for COC for 3 months followed by elagolix in combination with COC for 15 months.
 Drug: Elagolix
Tablet:Oral
Other Names:
  • ABT-620
  • Orilissa

Drug: Combined Oral Contraceptive (COC)
Tablet:Oral

Drug: Placebo for Elagolix
Tablet:Oral

Drug: Placebo for COC
Capsule:Oral


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale [ Time Frame: Month 3 ]
    DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.


Secondary Outcome Measures :
  1. Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale [ Time Frame: Month 3 ]
    NMPP response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333576


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04333576    
Other Study ID Numbers: M18-969
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Endometriosis
Elagolix
Combined oral contraceptives (COC)
Orilissa
Dysmenorrhea
Additional relevant MeSH terms:
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Endometriosis
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
 Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female