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Trial record 1 of 1 for:    03886220
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A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886220
Recruitment Status : Active, not recruiting
First Posted : March 22, 2019
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE March 20, 2019
First Posted Date  ICMJE March 22, 2019
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE April 12, 2019
Estimated Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2019)
Percentage of Participants with Menstrual Blood Loss (MBL) volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume from Baseline to the Final Month [ Time Frame: From Month 0 (Baseline) to Final Month (Month 6) ]
MBL is measured by the alkaline hematin method.
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
Percentage of Participants with Menstrual Blood Loss (MBL) volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume from Baseline to the Final Month [ Time Frame: From Month 0 (Baseline) to Final Month (Month 6) ]
MBL is measured by the alkaline hematin method
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
Change from Baseline in MBL volume [ Time Frame: Up to 6 Months ]
MBL is measured by the alkaline hematin method
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Official Title  ICMJE A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Brief Summary The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Uterine Fibroids
Intervention  ICMJE
  • Drug: Elagolix
    Oral; Tablet
    Other Names:
    • ABT-620
    • Elagolix Sodium
    • Orilissa
  • Drug: Placebo
    Oral; Tablet
Study Arms  ICMJE
  • Experimental: Participants receiving elagolix
    Participants will be administered with elagolix
    Intervention: Drug: Elagolix
  • Experimental: Participants receiving placebo
    Participants will be administered with placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 26, 2020)
43
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
150
Estimated Study Completion Date  ICMJE May 5, 2021
Estimated Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound [Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].
  • Participant has HMB associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin method.
  • Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.
  • Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.

Exclusion Criteria:

  • Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) or MRI (if SIS is unevaluable), results that show a clinically significant gynecological disorder.
  • Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.
  • Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
  • Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
  • Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 51 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries Hungary,   Poland
 
Administrative Information
NCT Number  ICMJE NCT03886220
Other Study ID Numbers  ICMJE M16-824
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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 and 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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP