7/10/2023 0 Comments Enzymex fibroidsUp to 70 % of African American women have uterine fibroids, and these generally tend to be larger, more numerous, and produce more severe symptoms. Known recent rapid growth of fibroids, defined as a doubling in size in six months.Uterine fibroids, also known as leiomyomas, are the most common tumor of the reproductive tract in women, occurring in over half of American women of reproductive age. Use of herbal medication having estrogenic or antiestrogenic effects within the past 3 months. Use of agents known to induct hepatic P450 enzymes use of imidazoles.Ĭurrent use of GnRH analogs or other compounds that affect menstrual cyclicity.ĮXCLUSION CRITERIA FOR WOMEN WITH FIBROIDS: Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations. History of malignancy within the past 5 years. Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year. Significant abnormalities in the history, physical or laboratory examination. No desire for fertility willing to undergo hysterectomy. Uterine leiomyoma(ta) of at least 2 cm size. Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection. History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994):Įxcessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days or anemia due to acute or chronic blood loss OR INCLUSION CRITERIA FOR WOMEN WITH LEIOMYOMA: Liver function tests within 130% of upper limit. ![]() Using mechanical (condoms, diaphragms), sterilization or abstinence methods of contraception for the duration of the study.Īble to read and speak English fluently to allow accurate self-administration of medication, recording of symptoms and unassisted completion of questionnaire. Willing and able to comply with study requirements. Interval use of over-the counter drugs is acceptable but must be recorded. Other chronic medication use may be acceptable at the discretion of the research team. Chronic medication use is acceptable except for glucocorticoid use. Women receiving insulin or thyroid hormone replacement may participate if well-controlled use of vitamins and calcium under RDA is allowed.įemale gender-to evaluate effects in the target population for clinical trials. Women will be randomly assigned to the treatment groups during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives. Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues, and to provide treatment for the study participant. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with fluid) of the uterus before and at the end of the treatment they will have blood drawn every 7 - 14 days, and will fill out a symptom calendar at home. This study will compare fibroid size, hormone levels and symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 - 14 weeks. A similar compound, mifepristone (Registered Trademark), reduced fibroid size when given for twelve weeks. The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914. ![]() Thus, many women with symptomatic fibroids choose to have them removed surgically, either individually or by removing the uterus via hysterectomy. However, such medication can only be given short-term and has inconvenient side effects such as hot-flushes. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. ![]() These tumors may cause bleeding, pelvic pain and pressure. Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in premenopausal women. Why Should I Register and Submit Results?.
0 Comments
Leave a Reply. |