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Safety and Efficacy Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01441635
First received: September 6, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this proof-of-concept study is to determine whether elagolix (ABT-620) is safe and effective in the treatment of pre-menopausal women, 20 to 49 years of age, with heavy uterine bleeding associated with uterine fibroids. The effect of elagolix (ABT-620) on uterine size, fibroid size, and bleeding associated with uterine fibroids will be assessed versus placebo, and in combination with add-back therapy.


Condition Intervention Phase
Heavy Uterine Bleeding
Uterine Fibroids
 Drug: Placebo
Drug: Elagolix, elagolix sodium
Drug: elagolix, elagolix sodium
Other: Elagolix Dose 1 plus estradiol/norethindrone acetate
Drug: Elagolix Dose 2 plus estradiol
Drug: Elagolix Dose 2 plus cyclical progesterone
 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: Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Assessment of Bleeding [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The mean change from baseline to the last menstrual cycle during treatment in uterine blood loss.

  • Assessment of Bleeding [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    The mean change from baseline to the last menstrual cycle during treatment in uterine blood loss.


Secondary Outcome Measures:
  • Number of Bleeding Days [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Change from baseline to Month 3 in Number of Bleeding Days

  • Number of Bleeding Days [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Change from baseline to Month 3 in Number of Bleeding Days

  • Menstrual Bleeding Scores [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Change from baseline to Month 3 in menstrual bleeding scores.

  • Menstrual Bleeding Scores [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Change from baseline to Month 3 in menstrual bleeding scores.

  • Uterine Volume [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from baseline to Month 3 in uterine volume

  • Uterine Volume [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Percent change from baseline to Month 3 in uterine volume

  • Hemoglobin Concentration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Change from baseline to Month 3 in hemoglobin concentration

  • Hemoglobin Concentration [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Change from baseline to Month 3 in hemoglobin concentration

  • Safety Evaluation - Adverse event monitoring [ Time Frame: Up to month 9 ] [ Designated as safety issue: Yes ]
  • Safety Evaluation - Vital signs [ Time Frame: 2 months prior to dosing ] [ Designated as safety issue: Yes ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: Month 2 ] [ Designated as safety issue: Yes ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: 3 Months Post Dosing ] [ Designated as safety issue: Yes ]
    Temperature, Blood Pressure and Pulse

  • Physical examinations (complete or symptom directed) [ Time Frame: Up to 3 months prior to dosing ] [ Designated as safety issue: Yes ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Month 2 ] [ Designated as safety issue: Yes ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
  • 12-Lead Electrocardiogram (ECG) [ Time Frame: Up to 3 months prior to dosing ] [ Designated as safety issue: Yes ]
  • 12-Lead Electrocardiogram (ECG) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • 12-Lead Electrocardiogram (ECG) [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
  • Bone Biomarkers [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Osteocalcin, CTX, P1NP

  • Bone Biomarkers [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
    Osteocalcin, CTX, P1NP

  • Bone Mineral Density (BMD) [ Time Frame: Up to 3 months prior to dosing ] [ Designated as safety issue: Yes ]
  • Bone Mineral Density (BMD) [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
  • Clinical Laboratory Tests [ Time Frame: up to 3 months prior to dosing ] [ Designated as safety issue: Yes ]
    hematology, chemistry, urinalysis, lipid panel

  • Clinical Laboratory Tests [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    hematology, chemistry, urinalysis, lipid panel

  • Clinical Laboratory Tests [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]
    hematology, chemistry, urinalysis, lipid panel

  • Clinical Laboratory Tests [ Time Frame: Month 2 ] [ Designated as safety issue: Yes ]
    hematology, chemistry, urinalysis, lipid panel

  • Clinical Laboratory Tests [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
    hematology, chemistry, urinalysis, lipid panel


Estimated Enrollment: 274
Study Start Date: September 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Cohort 1
Placebo
 Drug: Placebo
Placebo
Experimental: Elagolix Dose 1 Drug: Elagolix, elagolix sodium
Elagolix Dose 1
Placebo Comparator: Placebo Cohort 2 Drug: Placebo
Placebo
Experimental: Elagolix Dose 2 Drug: elagolix, elagolix sodium
Elagolix Dose 2
Experimental: Elagolix Dose 1 plus estradiol/norethindrone acetate
Elagolix Dose 1 plus estradiol/norethindrone acetate
 Other: Elagolix Dose 1 plus estradiol/norethindrone acetate
Elagolix Dose 1 plus estradiol/norethindrone acetate
Placebo Comparator: Placebo Cohort 4
Placebo
 Drug: Placebo
Placebo
Experimental: Elagolix Dose 3
Elagolix Dose 3
 Drug: Elagolix, elagolix sodium
Elagolix Dose 3
Experimental: Elagolix Dose 4
Elagolix Dose 4
 Drug: Elagolix, elagolix sodium
Elagolix Dose 4
Experimental: Elagolix Dose 5 Drug: elagolix, elagolix sodium
Elagolix Dose 5
Experimental: Elagolix Dose 2 plus estradiol
Elagolix Dose 2 plus estradiol
 Drug: Elagolix Dose 2 plus estradiol
Elagolix Dose 2 plus estradiol
Experimental: Elagolix Dose 2 plus cyclical progesterone
Elagolix Dose 2 plus cyclical progesterone
 Drug: Elagolix Dose 2 plus cyclical progesterone
Elagolix Dose 2 plus cyclical progesterone

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is a pre-menopausal female ≥ 20 years of age.
  • Subject has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
  • Subject has a history of regular menstrual cycles between 24 to 35 days.
  • Subject has heavy uterine bleeding associated with uterine fibroids.

Exclusion Criteria:

  • Subject has had a myomectomy, uterine artery embolization, endometrial ablation 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:

    • Endometriosis
    • Epilepsy or seizures
    • Type 1 diabetes
    • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441635

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

  Show 58 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Kristof Chwalisz, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01441635     History of Changes
Other Study ID Numbers: M12-663
Study First Received: September 6, 2011
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hemorrhage
Leiomyoma
Myofibroma
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
Estradiol
Polyestradiol phosphate
 Progesterone
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
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 23, 2013