Phase
Condition
Uterine Fibroids
Uterina Myoma
Desmoid Tumors
Treatment
N/AClinical Study ID
Ages 18-48 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablationtherapy (previous myomectomy is acceptable) for any cause and no surgicalinterventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterialembolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.
Exclusion
Exclusion Criteria:
Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to becomepregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), plateletdysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any gradeincluding atypical squamous cells of undetermined significance (ASCUS) associated withHuman Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs orany other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, orChlamydia or previous history of auto-immune disease or positive serum antinuclearantibodies.
Study Design
Study Description
Connect with a study center
Advanced Clinical Research Institute
,Anaheim, California 92801
United StatesSite Not Available
Advanced Clinical Research Institute
Anaheim, California 92801
United StatesSite Not Available
Impact Clinical Trials
Los Angeles, California 90057
United StatesSite Not Available
National Institute of Clinical Research
Los Angeles, California 90057
United StatesSite Not Available
Segal Institute for Clinical Research
Miami, Florida 33161
United StatesSite Not Available
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida 33409
United StatesSite Not Available
Phoenix Women's Center (eCast0
College Park, Georgia 30349
United StatesSite Not Available
Clinical Trials Select (eCast)
Decatur, Georgia 30030
United StatesSite Not Available
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
Decatur, Georgia 30035
United StatesSite Not Available
Medical Network for Education and Research
Decatur, Georgia 30333
United StatesSite Not Available
Smith & Hackney (eCast)
Morrow, Georgia 30260
United StatesSite Not Available
Bluegrass Clinical Research, Inc.
Louisville, Kentucky 40291
United StatesSite Not Available
Central Brooklyn Medical Group (eCast)
Brooklyn, New York 11205
United StatesSite Not Available
Rapid Medical Research, Inc. (Elite)
Cleveland, Ohio 44122
United StatesSite Not Available
HWC Women's Research Center
Englewood, Ohio 45322
United StatesSite Not Available
Chattanooga Medical Research, LLC
Chattanooga, Tennessee 37404
United StatesSite Not Available
Center for Women's Medicine
Houston, Texas 77079
United StatesSite Not Available
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