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Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

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ClinicalTrials.gov Identifier: NCT03186586
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Uterine bleeding control (stop bleeding) [ Time Frame: Three months ]
Uterine bleeding control (stop bleeding) among users of Mirena after use of UPA or placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03186586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Endometrial control [ Time Frame: Three months ]
Endometrial thickness
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena
Official Title  ICMJE Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena, a Randomized Clinical Trial
Brief 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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Heavy Menstrual Bleeding
  • Abnormal Bleeding
Intervention  ICMJE
  • Drug: Ulipristal acetate
    5mg/day/five days
  • Drug: Placebo
    Placebo one pill a day for 5 days at the bleeding episode
Study Arms  ICMJE
  • Experimental: Ulipristal acetate 5mg/day/five days
    Women with abnormal bleeding during use of Mirena will allocate to UPA or placebo Ulipristal acetate at 5mg/day/five days Ulipristal 5mg daily for 5 days at the bleeding episode
    Intervention: Drug: Ulipristal acetate
  • Placebo Comparator: Placebo 1 pill/day/five days
    Women with abnormal bleeding during use of Mirena will allocate to UPA or placebo Placebo at 1pill/day/five days Placebo one pill a day for 5 days at the bleeding episode
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2018
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Women with complaints of abnormal bleeding during use of Mirena independently of the length of use

Exclusion Criteria:

Delivery in the last six months Breastfeeding Hematological disorder Use of anticoagulants Uterine leiomioma

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luis Bahamondes, Md 55 19 32892856 ext 209 bahamond@caism.unicamp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03186586
Other Study ID Numbers  ICMJE CEMICAMP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Luis Bahamondes, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Campinas, Brazil
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP