Heavy Menstrual Bleeding Clinical Trial
Official title:
Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena, a Randomized Clinical Trial
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.
The LNG-IUS is a contraceptive method with high efficacy, long acting, reversible with
contraceptive failure between 0.1 and 0.5/100 women/year. It released 20 mcg/day of LNG with
a life span duration of 5 years. LNG is a synthetic progestin, 19-northestosterone, six times
more potent than progesterone, with androgenic properties and with binding with sexual
hormones, receptors of human steroids, including receptors of glucocorticoids and
mineralocorticoids, with minimal capacity of binding with estrogen receptors. At endometrium
level it induce antiproliferative effect and strong expression of local markers and
endometrial decidualization, including the prolactin receptor and insulin-like growth factor.
The mechanism of action includes effect upon cervical mucus which affects the sperm movements
through the reproductive tract which affects fertilization. In some women could be ovulation
inhibition. One of the main reason for discontinuation is breakdown bleeding, increase
bleeding or abnormal bleeding including heavy menstrual bleeding (HMB) and spotting which is
common at the first six month of use. Despite the fact that it is the main cause of
discontinuation, there is no effective treatment for these cases. An effective treatment
could help in the reduction of reduce the rates of discontinuation, improved the
cost-effectiveness and quality of life of users.
A selective progesterone receptor modulator (SPRM) is Ulipristal Acetate (UPA) is approved in
the European Union as Esmya® as a tretament to reduce the ueterine leiomyomas at te dose of 5
mg/day and it under evaluation at the dose of 5-10 mg as oral contraceptive.
This could be an option of treatment for HMB or abnormal bleeding induced by the LNG-IUS. UPA
is agonist/antagonist and binding with progesterone to the receptor level. It has ovarian and
endometrial activity, with dose-dependent effect in inhibition of ovulation and maturation of
the endometrium. There are restricted evidences, that the administration of UPA induce a
quick endometrial atrophy and stop the abnormal bleeding.
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