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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441635
First Posted: September 28, 2011
Last Update Posted: December 11, 2014
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.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  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 Other: Placebo Drug: Elagolix, elagolix sodium Drug: 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Assessment of Bleeding [ Time Frame: Day 1 ]
    The mean change from baseline to the last menstrual cycle during treatment in uterine blood loss.

  • Assessment of Bleeding [ Time Frame: Month 3 ]
    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 ]
    Change from baseline to Month 3 in Number of Bleeding Days

  • Number of Bleeding Days [ Time Frame: Month 3 ]
    Change from baseline to Month 3 in Number of Bleeding Days

  • Menstrual Bleeding Scores [ Time Frame: Day 1 ]
    Change from baseline to Month 3 in menstrual bleeding scores.

  • Menstrual Bleeding Scores [ Time Frame: Month 3 ]
    Change from baseline to Month 3 in menstrual bleeding scores.

  • Uterine Volume [ Time Frame: Day 1 ]
    Percent change from baseline to Month 3 in uterine volume

  • Uterine Volume [ Time Frame: Month 3 ]
    Percent change from baseline to Month 3 in uterine volume

  • Hemoglobin Concentration [ Time Frame: Day 1 ]
    Change from baseline to Month 3 in hemoglobin concentration

  • Hemoglobin Concentration [ Time Frame: Month 3 ]
    Change from baseline to Month 3 in hemoglobin concentration

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

  • Safety Evaluation - Vital signs [ Time Frame: Day 1 ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: Month 1 ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: Month 2 ]
    Temperature, Blood Pressure and Pulse

  • Safety Evaluation - Vital signs [ Time Frame: Month 3 ]
    Temperature, Blood Pressure and Pulse

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

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

  • Bone Biomarkers [ Time Frame: Month 3 ]
    Osteocalcin, CTX, P1NP

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

  • Clinical Laboratory Tests [ Time Frame: Day 1 ]
    hematology, chemistry, urinalysis, lipid panel

  • Clinical Laboratory Tests [ Time Frame: Month 1 ]
    hematology, chemistry, urinalysis, lipid panel

  • Clinical Laboratory Tests [ Time Frame: Month 2 ]
    hematology, chemistry, urinalysis, lipid panel

  • Clinical Laboratory Tests [ Time Frame: Month 3 ]
    hematology, chemistry, urinalysis, lipid panel


Enrollment: 271
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Cohort 1
Placebo
Other: Placebo
Placebo
Experimental: Elagolix Dose 1 Drug: Elagolix, elagolix sodium
Elagolix Dose 1
Other Name: ABT-620
Placebo Comparator: Placebo Cohort 2 Other: Placebo
Placebo
Experimental: Elagolix Dose 2 Drug: Elagolix, elagolix sodium
Elagolix Dose 2
Other Name: ABT-620
Experimental: Elagolix Dose 1 plus estradiol/norethindrone acetate
Elagolix Dose 1 plus estradiol/norethindrone acetate
Drug: Elagolix Dose 1 plus estradiol/norethindrone acetate
Elagolix Dose 1 plus estradiol/norethindrone acetate
Placebo Comparator: Placebo Cohort 4
Placebo
Other: Placebo
Placebo
Experimental: Elagolix Dose 3
Elagolix Dose 3
Drug: Elagolix, elagolix sodium
Elagolix Dose 3
Other Name: ABT-620
Experimental: Elagolix Dose 4
Elagolix Dose 4
Drug: Elagolix, elagolix sodium
Elagolix Dose 4
Other Name: ABT-620
Experimental: Elagolix Dose 5 Drug: Elagolix, elagolix sodium
Elagolix Dose 5
Other Name: ABT-620
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes 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
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): NCT01441635


  Show 56 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Kristof Chwalisz, MD AbbVie
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01441635     History of Changes
Other Study ID Numbers: M12-663
First Submitted: September 6, 2011
First Posted: September 28, 2011
Last Update Posted: December 11, 2014
Last Verified: November 2014

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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 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
Progestins
Contraceptives, Oral, Synthetic