Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena
Status:
Unknown status
Trial end date:
2018-07-30
Target enrollment:
Participant gender:
Summary
Objectives: To assess if the administration of ulipristal acetate (UPA) in users of the
levonorgestrel-releasing intrauterine system (LNG-IUS) with breakdown bleeding or abnormal
bleeding, could be able to inhibit the bleeding and if this effect will be sustainable up to
three months after treatment.
Material and methods: A total of 32 women aged between 18-45 years, users of the LNG-IUS with
breakdown bleeding, abnormal bleeding or prolonged bleeding (bleeding more than 14 days) or
episodes of bleeding with intervals less than 24 days). The study is an experimental, double
blind randomized (16 women will receive UPA 5 mg/day/5 days; 16 women will receive placebo/1
time/day/5 day). The women will invited to participated at the Family Planning clinic at the
day they consulted with the complaint of bleeding. That day they will allocated at random to
UPA or placebo group. They will oriented to fill out a bleeding calendar through 90 days
after the pill intake. In addition a ultrasonography scan will be perform before the first
day of pill intake and at 90 days after.
Statistical analysis: A a pilot study the sample was estimated in 26 women (13 at each group)
based at the estimative of success of 0.95 with UPA and 0.35 with placebo with significance
of 0.05 and power of 80%. The sociodemographic characteristics will be analyzed as mean and
SD and will compared through Mann-Whitney, Yates χ2 and Fisher exact tests as apropriate.
Also, a regression analysis (Poisson analysis) with the dependent significant variables. The
established level of significance will be p < 0.05.