Phase
Condition
Uterine Fibroids
Desmoid Tumors
Leiomyomas
Treatment
N/AClinical Study ID
Ages > 21 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥21 years old
Premenopausal (at least one menses in last 3 months)
Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterinebleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)
Fibroids that are ≤4 in total number or Fibroids that are ≤7 in total number if allfibroids are less than 4cm (40 mm) each
Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids intotal number(fibroid is defined as any mass with radiographic characteristics offibroid >2cm)
Up to date in Pap smear screening and surveillance
Endometrial biopsy (required if age>45 years with irregular bleeding) does notindicate premalignant or malignant cells
Agree to use non-hormonal barrier method of contraception during study period if atrisk for pregnancy
Has primary care provider or gynecologist
Agrees not to start new medications/treatments for fibroids during the study
Able to give informed consent
Exclusion
Exclusion Criteria:
Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist inthe last 3 months
Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1fibroids) amenable to hysteroscopic resection
Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-actingdepoprovera injection, no use in last 3 months)
Pregnant, lactating, or planning to become pregnant in the next 6 months
Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms inthe last 3 months (cannot be safely randomized to a placebo)
History of osteopenia or osteoporosis
History of hyperlipidemia
Current liver or kidney disease
Unable or unwilling to attend 4 study visits
Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary orgastrointestinal system
Does not have primary care provider or gynecologist
Study Design
Connect with a study center
University of California, San Francisco
San Francisco, California 94158
United StatesSite Not Available

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