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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01817530
First received: March 21, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in Menstrual Blood Loss [ Time Frame: From Baseline to Month 6 ] [ Designated as safety issue: No ]
    Change in menstrual blood loss measured by alkaline hematin method


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

  • Change in Clinical Laboratory Tests [ Time Frame: From Day 1 up to 3 Months Post-dosing ] [ Designated as safety issue: Yes ]
    Chemistry, Urinalysis, complete blood count, bone biomarkers, lipid profile

  • Percentage of Subjects with reduction in Menstrual Blood Loss [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
  • Percentage Subjects with amenorrhea [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
  • Percentage of Subjects with No Bleeding (spotting allowed) [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
  • Number of Bleeding Days [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
  • Percent Change from baseline in bleeding scores per bleeding diary [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: No ]
  • Percent Change in Uterine Volume [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: No ]
  • Percent Change in Fibroid Volume [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: No ]
  • Percent change in hemoglobin concentration [ Time Frame: From Day 1 through Month 6 ] [ Designated as safety issue: No ]
  • Change in bone mineral density [ Time Frame: From 3 months prior to dosing through 6 months post-dosing ] [ Designated as safety issue: Yes ]
  • Change in percentage of subjects with hypoestrogenic effects [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: Yes ]
  • Proportion reporting treatment-emergent adverse events [ Time Frame: Up to 6 months post-dosing ] [ Designated as safety issue: Yes ]
  • Change from Baseline in the percent of subjects with adverse events [ Time Frame: From Day 1 through 6 months post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 520
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Elagolix
Elagolix Dose 2 for 6 Month Treatment Period
Other Name: ABT-620
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: Elagolix
Elagolix Dose 2 for 6 Month Treatment Period
Other Name: ABT-620
Drug: Estradiol/norethindrone acetate
E2/NETA Dose 2

  Eligibility

Ages Eligible for Study:   18 Years to 51 Years
Genders 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 1 year prior to randomization or any history of endometrial ablation.
  • 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), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.
  • 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 basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817530

Contacts
Contact: Laura Wagner, BS 847-938-2554 laura.s.wagner@abbvie.com
Contact: Janine North, BS 847-938-1999 janine.north@AbbVie.com

  Show 127 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Kristof Chwalisz, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01817530     History of Changes
Other Study ID Numbers: M12-813, 2013-000082-37
Study First Received: March 21, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Hemorrhage
Menorrhagia
Uterine Hemorrhage
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 valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014