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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

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.


Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Abnormal Bleeding Drug: Ulipristal acetate Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena, a Randomized Clinical Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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
Drug: Ulipristal acetate
5mg/day/five days

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
Drug: Placebo
Placebo one pill a day for 5 days at the bleeding episode




Primary Outcome Measures :
  1. Uterine bleeding control (stop bleeding) [ Time Frame: Three months ]
    Uterine bleeding control (stop bleeding) among users of Mirena after use of UPA or placebo


Secondary Outcome Measures :
  1. Endometrial control [ Time Frame: Three months ]
    Endometrial thickness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186586


Contacts
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Contact: Luis Bahamondes, Md 55 19 32892856 ext 209 bahamond@caism.unicamp.br

Locations
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Brazil
University of Campinas Recruiting
Campinas, SP, Brazil, 13083888
Contact: Luis Bahamondes, Md    55 19 32892856 ext 209    bahamond@caism.unicamp.br   
Sponsors and Collaborators
University of Campinas, Brazil

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Responsible Party: Luis Bahamondes, Professor of Gynecology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03186586     History of Changes
Other Study ID Numbers: CEMICAMP
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luis Bahamondes, University of Campinas, Brazil:
Heavy Menstrual Bleeding
Levonorgestrel relesing intrauterine system

Additional relevant MeSH terms:
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Hemorrhage
Uterine Hemorrhage
Menorrhagia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Levonorgestrel
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral