NCT03186586

Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

Status unknown Phase 4 Last updated 3 May 2018

What this trial tests

Phase 4 trial testing Ulipristal acetate in Heavy Menstrual Bleeding in 32 participants. Status unknown.

Timeline

1 July 2017

Primary endpoint
30 July 2018

30 July 2018

Quick facts

Lead sponsor	University of Campinas, Brazil
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	32
Start date	1 July 2017
Primary completion	30 July 2018
Estimated completion	30 July 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Ulipristal acetate — full drug profile →
• Placebo

Conditions studied

• Heavy Menstrual Bleeding — all drugs for Heavy Menstrual Bleeding →
• Abnormal Bleeding — all drugs for Abnormal Bleeding →

Sponsor

University of Campinas, Brazil

Who can join

Adults 18 to 45, female only, with Heavy Menstrual Bleeding or Abnormal Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.
   Islam MS, Afrin S, Jones SI, Segars J. · · 2020 · cited 97× · PMID 32365199 · DOI 10.1210/endrev/bnaa012
2. A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system.
   Fava M, Peloggia A, Baccaro LF, Castro S, et al · · 2020 · cited 10× · PMID 31777949 · DOI 10.1002/ijgo.13068
3. Interventions to prevent or treat heavy menstrual bleeding or pain associated with intrauterine-device use.
   Christelle K, Norhayati MN, Jaafar SH. · · 2022 · cited 4× · PMID 36017945 · DOI 10.1002/14651858.cd006034.pub3