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A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids


Phase 2
18 Years
49 Years
Open (Enrolling)
Female
Heavy Uterine Bleeding, Uterine Fibroids

Thank you

Trial Information

A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids


Inclusion Criteria:



- Subject is pre-menopausal female 18 to 49 years of age at Screening.

- Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.

- Subject has 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 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

- 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

Type of Study:

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

Outcome Measure:

Change in Menstrual Blood Loss

Outcome Description:

Change in menstrual blood loss measured by alkaline hematin method

Outcome Time Frame:

From Baseline to Month 6

Safety Issue:

No

Principal Investigator

Kristof Chwalisz, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M12-813

NCT ID:

NCT01817530

Start Date:

March 2013

Completion Date:

January 2015

Related Keywords:

  • Heavy Uterine Bleeding
  • Uterine Fibroids
  • ABT-620
  • Elagolix
  • Uterine Fibroids
  • Elagolix sodium
  • Heavy Uterine Bleeding
  • Leiomyomata
  • Menorrhagia
  • Hemorrhage
  • Leiomyoma
  • Myofibroma
  • Menorrhagia
  • Uterine Hemorrhage

Name

Location
Site Reference ID/Investigator# 81847 Los Angeles, California  90036
Site Reference ID/Investigator# 82223 San Diego, California  92108
Site Reference ID/Investigator# 82113 Boynton Beach, Florida  33472
Site Reference ID/Investigator# 82213 West Palm Beach, Florida  33409
Site Reference ID/Investigator# 81842 Atlanta, Georgia  30342
Site Reference ID/Investigator# 82221 Bay City, Michigan  48706
Site Reference ID/Investigator# 82234 Memphis, Tennessee  38119