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No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.
Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Published on BioPortfolio: 2014-08-27T03:51:26-0400
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to preme...
The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.
The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
Under physiological conditions, noradrenaline (NA) and adrenergic receptors (ARs) are implicated in the function of the uterus. The role of NA and the expression of ARs in the inflamed uterus is not f...
Uterine fibroids (UFs) are clonal, hormonally-regulated benign smooth muscle myometrial tumors that severely affect female reproductive health, although their unknown etiology limits effective care. U...
Uterine leiomyomas (fibroids) are the most common type of uterine neoplasms in premenopausal women. Leiomyomas are estrogen dependent and tend to atrophy and shrink in size after menopause. Dystrophic...
A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues.
A condition in which the UTERUS is found tilted backward toward the spine. The uterus is more commonly found in a straight vertical or anteverted (tipped forward) position. Although retroverted uterus is a normal variant position without symptoms, it is sometimes associated with pain, discomfort and other pregnancy complications.
A fibromuscular band that attaches to the UTERUS and then passes along the BROAD LIGAMENT, out through the INGUINAL RING, and into the labium majus.
A type of pregnancy in which the EMBRYO IMPLANTATION occurs in the horn of the UTERUS instead of in the uterine cavity, i.e. at the junction of the uterus and one of the FALLOPIAN TUBES.
Appendages of the UTERUS which include the FALLOPIAN TUBES, the OVARY, and the supporting ligaments of the uterus (BROAD LIGAMENT; ROUND LIGAMENT).
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