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Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

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ClinicalTrials.gov Identifier: NCT01817530
Recruitment Status : Completed
First Posted : March 25, 2013
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

Condition or disease Intervention/treatment Phase
Heavy Uterine Bleeding Uterine Fibroids Other: Placebo Drug: Elagolix Drug: Estradiol/norethindrone acetate, E2/NETA Drug: Estradiol/norethindrone acetate, E2/NETA Dose 2 Drug: Estradiol/norethindrone acetate Phase 2

Detailed Description:
January 2013 was an estimated study start date. April 8, 2013 was the date of signed consent for the first dosed patient.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Actual Study Start Date : April 8, 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo 1
Placebo
 Other: Placebo
Placebo for 6 Month Treatment Period
Experimental: Elagolix Dose 1
Elagolix Dose 1
 Drug: Elagolix
Elagolix Dose 1 for 6 Month treatment Period
Other Name: ABT-620
Experimental: Elagolix Dose 1 plus E2/NETA Dose 1
Elagolix Dose 1 plus E2/NETA (estradiol/norethindrone acetate) Dose 1
 Drug: Elagolix
Elagolix Dose 1 for 6 Month treatment Period
Other Name: ABT-620

Drug: Estradiol/norethindrone acetate, E2/NETA
E2/NETA Dose 1
Experimental: Elagolix Dose 1 plus E2/NETA Dose 2
Elagolix Dose 1 plus E2/NETA (estradiol/norethindrone acetate) Dose 2
 Drug: Elagolix
Elagolix Dose 1 for 6 Month treatment Period
Other Name: ABT-620

Drug: Estradiol/norethindrone acetate, E2/NETA Dose 2
E2/NETA Dose 2
Placebo Comparator: Placebo 2
Placebo
 Other: Placebo
Placebo for 6 Month Treatment Period
Experimental: Elagolix Dose 2
Ealgolix Dose 2
 Drug: Elagolix
Elagolix Dose 2 for 6 Month Treatment Period
Other Name: ABT-620
Experimental: Elagolix Dose 2 plus E2/NETA Dose 1
Elagolix Dose 2 plus E2/NETA (estradiol/norethindrone acetate) Dose 1
 Drug: Estradiol/norethindrone acetate, E2/NETA
E2/NETA Dose 1
Experimental: Elagolix Dose 2 plus E2/NETA Dose 2
Elagolix Dose 2 plus E2/NETA (estradiol/norethindrone acetate) Dose 2
 Drug: Estradiol/norethindrone acetate
E2/NETA Dose 2


Outcome Measures
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Primary Outcome Measures :
  1. Change in Menstrual Blood Loss [ Time Frame: From Baseline to Month 6 ]
    Change in menstrual blood loss measured by alkaline hematin method


Secondary Outcome Measures :
  1. Change in Physical Examination [ Time Frame: From Day 1 through 6 Months Post-dosing ]
  2. Change from Baseline in the number of subjects with adverse events [ Time Frame: From Day 1 through 6 months post dose ]
  3. Change in Bone Mineral Density (BMD) [ Time Frame: From Day 1 through Month 6 ]
  4. Change in Endometrial Assessment [ Time Frame: From 3 months prior to dosing up to 6 Months Post-dosing ]
    Change in endometrial thickness

  5. Change in Clinical Laboratory Tests [ Time Frame: From Day 1 up to 3 Months Post-dosing ]
    Chemistry, Urinalysis, complete blood count, bone biomarkers, lipid profile

  6. Percentage of Subjects with reduction in Menstrual Blood Loss [ Time Frame: Up to Month 6 ]
  7. Percentage Subjects with amenorrhea [ Time Frame: Up to Month 6 ]
  8. Percentage of Subjects with No Bleeding (spotting allowed) [ Time Frame: Up to Month 6 ]
  9. Number of Bleeding Days [ Time Frame: Up to Month 6 ]
  10. Percent Change from baseline in bleeding scores per bleeding diary [ Time Frame: From Day 1 to Month 6 ]
  11. Percent Change in Uterine Volume [ Time Frame: From Day 1 to Month 6 ]
  12. Percent Change in Fibroid Volume [ Time Frame: From Day 1 to Month 6 ]
  13. Percent change in hemoglobin concentration [ Time Frame: From Day 1 through Month 6 ]
  14. Change in bone mineral density [ Time Frame: From 3 months prior to dosing through 6 months post-dosing ]
  15. Change in percentage of subjects with hypoestrogenic effects [ Time Frame: From Day 1 to Month 6 ]
  16. Proportion reporting treatment-emergent adverse events [ Time Frame: Up to 6 months post-dosing ]
  17. Change from Baseline in the percent of subjects with adverse events [ Time Frame: From Day 1 through 6 months post dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Subject is pre-menopausal female 18 to 51 years of age at Screening.

  • Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
  • Subject has heavy uterine bleeding associated with uterine fibroids. Exclusion Criteria: - Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
  • Subject has a history of osteoporosis or other metabolic bone disease.
  • Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
  • Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
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): NCT01817530


  Show 100 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Charlotte Owens, MD AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01817530     History of Changes
Other Study ID Numbers: M12-813
2013-000082-37 ( EudraCT Number )
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Keywords provided by AbbVie:
Uterine Fibroids
Leiomyomata
Elagolix
Menorrhagia
 Elagolix sodium
Heavy Uterine Bleeding
ABT-620

Additional relevant MeSH terms:
Hemorrhage
Leiomyoma
Myofibroma
Uterine Hemorrhage
Menorrhagia
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
 Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic