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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


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

Thank you

Trial Information

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


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

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:

Assessment of Bleeding

Outcome Description:

The mean change from baseline to the last menstrual cycle during treatment in uterine blood loss.

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

Kristof Chwalisz, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M12-663

NCT ID:

NCT01441635

Start Date:

September 2011

Completion Date:

April 2014

Related Keywords:

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

Name

Location

Site Reference ID/Investigator# 48144 Phoenix, Arizona  85015
Site Reference ID/Investigator# 50273 Tucson, Arizona  85712
Site Reference ID/Investigator# 50279 La Mesa, California  91942
Site Reference ID/Investigator# 48139 San Diego, California  92103
Site Reference ID/Investigator# 48148 San Diego, California  92108
Site Reference ID/Investigator# 57881 San Diego, California  92123
Site Reference ID/Investigator# 58906 San Francisco, California  94115
Site Reference ID/Investigator# 48142 Colorado Springs, Colorado  80907
Site Reference ID/Investigator# 50275 Lakewood, Colorado  80228
Site Reference ID/Investigator# 48103 Boynton Beach, Florida  33472
Site Reference ID/Investigator# 48163 New Port Richey, Florida  34652
Site Reference ID/Investigator# 58482 North Miami, Florida  33161
Site Reference ID/Investigator# 48140 South Miami, Florida  33143
Site Reference ID/Investigator# 51491 West Palm Beach, Florida  33409
Site Reference ID/Investigator# 58625 Augusta, Georgia  30909
Site Reference ID/Investigator# 48137 Sandy Springs, Georgia  30328
Site Reference ID/Investigator# 48164 Chicago, Illinois  60612
Site Reference ID/Investigator# 48153 Naperville, Illinois  60540
Site Reference ID/Investigator# 54378 New Orleans, Louisiana  70115
Site Reference ID/Investigator# 57559 Fall River, Massachusetts  02720
Site Reference ID/Investigator# 54063 Saginaw, Michigan  48604
Site Reference ID/Investigator# 57558 Chaska, Minnesota  55318
Site Reference ID/Investigator# 50272 Missoula, Montana  59808
Site Reference ID/Investigator# 58622 Las Vegas, Nevada  89128
Site Reference ID/Investigator# 54369 Plainsboro, New Jersey  08536
Site Reference ID/Investigator# 59722 Brooklyn, New York  11203
Site Reference ID/Investigator# 55109 Durham, North Carolina  27713
Site Reference ID/Investigator# 54368 Raleigh, North Carolina  27612
Site Reference ID/Investigator# 48146 Winston-Salem, North Carolina  27103
Site Reference ID/Investigator# 48156 Winston-Salem, North Carolina  27103
Site Reference ID/Investigator# 54375 Portland, Oregon  97239
Site Reference ID/Investigator# 54372 Jenkintown, Pennsylvania  19046
Site Reference ID/Investigator# 50271 Philadelphia, Pennsylvania  19102
Site Reference ID/Investigator# 48102 Philadelphia, Pennsylvania  19114
Site Reference ID/Investigator# 58626 Bristol, Tennessee  37620
Site Reference ID/Investigator# 57561 Memphis, Tennessee  38119
Site Reference ID/Investigator# 54142 Nashville, Tennessee  37203
Site Reference ID/Investigator# 54377 Dallas, Texas  75390
Site Reference ID/Investigator# 48158 Houston, Texas  77030
Site Reference ID/Investigator# 57402 Houston, Texas  77054
Site Reference ID/Investigator# 48145 San Antonio, Texas  79229
Site Reference ID/Investigator# 48168 Sandy, Utah  84070
Site Reference ID/Investigator# 54370 Norfolk, Virginia  23502
Site Reference ID/Investigator# 48160 Richmond, Virginia  23225
Site Reference ID/Investigator# 48149 Seattle, Washington  98105
Site Reference ID/Investigator# 66423 Carmichael, California  95608
Site Reference ID/Investigator# 89654 Los Angeles, California  90036
Site Reference ID/Investigator# 77573 Debary, Florida  32713
Site Reference ID/Investigator# 77575 Fort Lauderdale, Florida  33316
Site Reference ID/Investigator# 65924 Lake Worth, Florida  33461
Site Reference ID/Investigator# 89653 Nashville, Tennessee  37208
Site Reference ID/Investigator# 77574 Irving, Texas  75061