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