Genève, United Kingdom
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Donnez J.,Catholic University of Leuven | Tomaszewski J.,Prywatna Klinika Polozniczo Ginekologiczna | Bouchard P.,University Paris - Sud | Lemieszczuk B.,Gabinet Lekarski Specjalistyczny Sonus | And 8 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear. METHODS: In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of -20%. RESULTS: Uterine bleeding was controlled in 90% of patients receiving 5 mg of ulipristal acetate, in 98% of those receiving 10 mg of ulipristal acetate, and in 89% of those receiving leuprolide acetate, for differences (as compared with leuprolide acetate) of 1.2 percentage points (95% confidence interval [CI], -9.3 to 11.8) for 5 mg of ulipristal acetate and 8.8 percentage points (95% CI, 0.4 to 18.3) for 10 mg of ulipristal acetate. Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal acetate, 5 days for those receiving 10 mg of ulipristal acetate, and 21 days for those receiving leuprolide acetate. Moderate-to-severe hot flashes were reported for 11% of patients receiving 5 mg of ulipristal acetate, for 10% of those receiving 10 mg of ulipristal acetate, and for 40% of those receiving leuprolide acetate (P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate). CONCLUSIONS: Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to oncemonthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes. (Funded by PregLem; ClinicalTrials.gov number, NCT00740831.) Copyright © 2012 Massachusetts Medical Society.


Donnez J.,Catholic University of Leuven | Tatarchuk T.F.,Kiev City Clinical Hospital No 16 | Bouchard P.,University Paris - Sud | Puscasiu L.,Spitalul Clinic Judetean de Urgenta | And 9 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. METHODS:We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of >100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to >500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of <75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. RESULTS: At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, 92% of those receiving 10 mg of ulipristal acetate, and 19% of those receiving placebo (P<0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, 82%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were -21%, -12%, and +3% (P = 0.002 for the comparison of 5 mg of ulipristal acetate with placebo, and P = 0.006 for the comparison of 10 mg of ulipristal acetate with placebo). Ulipristal acetate induced benign histologic endometrial changes that had resolved by 6 months after the end of therapy. Serious adverse events occurred in one patient during treatment with 10 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. CONCLUSIONS: Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids. (Funded by PregLem; ClinicalTrials.gov number, NCT00755755.) Copyright © 2012 Massachusetts Medical Society.


Trademark
Preglem Inc. | Date: 2016-08-04

pharmaceutical preparations for the treatment of female reproductive issues.


Trademark
Preglem Inc. | Date: 2016-08-04

pharmaceutical preparations for the treatment of female reproductive issues.


Trademark
Preglem Inc. | Date: 2016-08-04

pharmaceutical preparations for the treatment of female reproductive issues.


Trademark
Preglem Inc. | Date: 2016-08-04

pharmaceutical preparations for the treatment of female reproductive issues.


Trademark
Preglem Inc. | Date: 2016-08-04

pharmaceutical preparations for the treatment of female reproductive issues.


Trademark
Preglem Inc. | Date: 2012-01-17

Pharmaceutical for human use for the prevention and treatment of reproductive diseases and disorders; medical preparations for human use for the prevention and treatment of reproductive diseases and disorders; biotechnological preparations for medical purposes for human use. Advertising and promotion services for pharmaceutical, biotechnological or medical preparations for human use of others; retail and wholesale store services featuring pharmaceutical, biotechnological or medical preparations for human use. Medical services.


Trademark
Preglem Inc. | Date: 2012-11-27

Medicinal preparations for the prevention and treatment of reproductive diseases and disorders; pharmaceutical preparations for the prevention and treatment of reproductive diseases and disorders; biological preparations for diagnostic purposes, treatment and prevention of conditions, namely, for the prevention and treatment of reproductive diseases and disorders. Advertising and promotion services; retail store services featuring pharmaceutical, medicinal and biological preparations for diagnostic purposes, for treatment and prevention of reproductive diseases and disorders; the bringing together, for the benefit of others, of pharmaceutical, biological or medicinal preparations enabling customers to conveniently view and purchase those goods; the aforementioned excluding the transport of said goods. Medical services.


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