In women with fibroids, bleeding control was 89% with leuprolide versus 90% with ulipristal 5 mg, with an ulipristal-minus-leuprolide difference of 1.2 percentage points (95% CI, -9.3 to 11.8).
In plain wordsIn women with fibroids, leuprolide controlled bleeding in 89% versus 90% with ulipristal 5 mg.
- Peptide
- Leuprolide
- Outcome
- DecreaseControlled uterine bleeding versus ulipristal 5 mg
- Study
n: not reported in source
- Comparator
- Ulipristal acetate 5 mg daily
- Analysis
- Primary
- Outcome group
- Sex hormones and fertility · Reproductive and sexual health
- Studied dose
- 3.75 mg once monthly · intramuscular · 3 monthsAs given in this study (human).
Measurements
- Patients with controlled uterine bleeding at week 13
- 89%
- leuprolide acetate 3.75 mg monthly
- Patients with controlled uterine bleeding at week 13
- 90%
- ulipristal acetate 5 mg
- Difference in controlled bleeding, ulipristal 5 mg minus leuprolide
- 1.2 percentage points
- 95% CI, -9.3 to 11.8
Source sentences
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,
3 context sentences(design, population, supporting numbers)
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.
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 (…
The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of -20%.