ABSTRACT: To determine efficacy and safety of asoprisnil in patients with leiomyomata.
Phase 2, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study.
Twenty-eight sites in the United States and 1 in Canada.
One hundred twenty-nine women with leiomyomata.
Asoprisnil (5, 10, or 25 mg) or placebo orally daily for 12 weeks.
Uterine bleeding changes by using daily bleeding diaries, hemoglobin concentrations, dominant leiomyoma and uterus volume measured sonographically, patient-reported symptoms related to bloating and pelvic pressure, endometrial thickness and morphology, hormonal parameters, and standard safety measures.
Asoprisnil suppressed uterine bleeding in 28%, 64%, and 83% of subjects at 5, 10, and 25 mg, respectively, and reduced leiomyoma and uterine volumes. Median percentage decrease from baseline in leiomyoma volume was statistically significant at 25 mg compared with placebo after 4 and 8 weeks of treatment; by week 12, leiomyoma volume was reduced by 36%. There was a significant reduction in bloating with the two highest doses and in pelvic pressure with 25 mg by week 12. Asoprisnil was associated with follicular-phase estrogen concentration and minimal hypoestrogenic symptoms.
After 12-week treatment, asoprisnil controlled uterine bleeding while reducing leiomyoma volume and the associated pressure symptoms. Asoprisnil was well tolerated.
Fertility and sterility 07/2007; 87(6):1399-412. · 3.97 Impact Factor
ABSTRACT: Endometriosis is a condition that often leads to a variety of symptoms that range from pain complaints to infertility. Endometriosis is also found in women who are asymptomatic. The diagnosis of endometriosis can be made clinically with reliability similar to that of one made surgically. Medical treatment options are effective, as are surgical treatment options. Complications associated with surgery, however, push the balance in favor of medical therapy whenever possible. Based on the body of evidence available at present, women with endometriosis-related complaints should be treated with a first-line medical therapy. If that fails, a second-line medical therapy is warranted under most conditions. Laparoscopic surgery should be reserved for patients in whom second-line medical therapy has failed or is contraindicated by desire to conceive immediately or as soon as possible.
Obstetrics and Gynecology 09/2003; 102(2):397-408. · 4.73 Impact Factor
ABSTRACT: To determine and compare the costs associated with uterine artery embolization (UAE) and abdominal myomectomy for the treatment of symptomatic leiomyomata.
Charge information was gathered and analyzed from 23 patients who underwent UAE and 17 who underwent abdominal myomectomy in a single institution. The mean charges for each procedure were calculated from the patients' billing data. Cost-to-charge ratios were applied to the mean charges to estimate costs. The work relative value units (RVUs) for all physician services for each procedure were calculated. These total work RVUs for each intervention were multiplied by the appropriate Medicare conversion factors to estimate a uniform physician fee. These costs were totaled and compared with use of the unpaired t test to estimate the cost difference between UAE and abdominal myomectomy.
The estimated hospital cost for UAE was $3,193, which was significantly lower than the $5,598 estimated for abdominal myomectomy (P <.0001). The discrepancy was caused primarily by increased hospital care and operating room costs for abdominal myomectomy. The total professional costs were significantly higher for UAE ($2,220) than for abdominal myomectomy ($1,611) (P =.002). When all associated costs, including typical imaging costs, were considered, there was a trend toward lower costs for UAE ($6,708) compared to abdominal myomectomy ($7,630) (P =.086).
UAE had lower procedure-related costs than abdominal myomectomy despite higher physician costs. When typical imaging costs were included, there was still a trend toward lower costs for UAE.
Journal of Vascular and Interventional Radiology 12/2002; 13(12):1207-10. · 2.08 Impact Factor
ABSTRACT: To develop recommendations for the medical and surgical care of women who present with chronic pelvic pain (CPP) and are likely to have endometriosis as the underlying cause.
An expert panel comprised of practicing gynecologists from throughout the United States and experts in consensus guideline development was convened. After completion of a structured literature search and creation of draft algorithms by an executive committee, the expert panel of >50 practicing gynecologists met for a 2-day consensus conference during which the clinical recommendations and algorithms were reviewed, refined, and then ratified by unanimous or near-unanimous votes.
Women presenting with CPP who are likely to have endometriosis as the underlying cause.
Chronic pelvic pain frequently occurs secondary to nongynecologic conditions that must be considered in the evaluation of affected women. For women in whom endometriosis is the suspected cause of the pain, laparoscopic confirmation of the diagnosis is unnecessary, and a trial of medical therapy, including second-line therapies such as danazol, GnRH agonists, and progestins, is justified provided that there are no other indications for surgery such as the presence of a suspicious adnexal mass. When surgery is necessary, laparoscopic approaches seem to offer comparable clinical outcomes to those performed via laparotomy, but with reduced morbidity. The balance of evidence supports the use of adjuvant postoperative medical therapy after conservative surgery for CPP. There is some evidence that adjuvant presacral neurectomy adds benefit for midline pain, but currently, there is inadequate evidence to support the use of uterosacral nerve ablation or uterine suspension. Hysterectomy alone has undocumented value in the surgical management of women with endometriosis-associated CPP.
Fertility and Sterility 11/2002; 78(5):961-72. · 3.56 Impact Factor
ABSTRACT: To correlate the diagnosis of endometriosis in lesions excised at laparoscopy with pathologic diagnosis.
U.S. government research hospital.
Women with chronic pelvic pain thought to be due to endometriosis.
Excision of lesions suspicious for endometriosis.
Histologic examination of lesions for color, width, depth, and location of endometriosis. Lesion colors were grouped as black, red, white, mixed color, or endometriomas.
Sixty-five women with a surgical diagnosis of endometriosis had minimal (n = 22), mild (n = 25), moderate (n = 9), or severe disease (n = 9) according to the revised American Fertility Society classification. Endometriosis was confirmed in all but seven patients with minimal and one with severe disease. Twelve other patients did not have endometriosis. Of 314 lesions excised, 189 (61%) were endometriotic. Black or red lesions were less often histologically confirmed to be endometriosis than were white lesions, mixed-color lesions or endometriomas. Lesions > 5 mm wide or deep were more likely to be endometriosis than were narrower or shallower implants. Endometriomas deeper than 1 cm were histologically confirmed to be endometriosis, and 50% of peritoneal windows contained endometriosis.
White lesions, mixed-color lesions, endometriomas, and larger lesions by depth or width were more likely to be histologically confirmed endometriosis than were smaller, black, or red lesions.
Fertility and Sterility 10/2002; 78(4):743-9. · 3.56 Impact Factor