search
Back to results

Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

Primary Purpose

Heavy Menstrual Bleeding, Abnormal Bleeding

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Ulipristal acetate
Placebo
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding focused on measuring Heavy Menstrual Bleeding, Levonorgestrel relesing intrauterine system

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of CampinasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ulipristal acetate 5mg/day/five days

Placebo 1 pill/day/five days

Arm Description

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

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

Outcomes

Primary Outcome Measures

Uterine bleeding control (stop bleeding)
Uterine bleeding control (stop bleeding) among users of Mirena after use of UPA or placebo

Secondary Outcome Measures

Endometrial control
Endometrial thickness

Full Information

First Posted
December 12, 2016
Last Updated
May 2, 2018
Sponsor
University of Campinas, Brazil
search

1. Study Identification

Unique Protocol Identification Number
NCT03186586
Brief Title
Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena
Official Title
Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Menstrual Bleeding, Abnormal Bleeding
Keywords
Heavy Menstrual Bleeding, Levonorgestrel relesing intrauterine system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ulipristal acetate 5mg/day/five days
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo 1 pill/day/five days
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ulipristal acetate
Intervention Description
5mg/day/five days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo one pill a day for 5 days at the bleeding episode
Primary Outcome Measure Information:
Title
Uterine bleeding control (stop bleeding)
Description
Uterine bleeding control (stop bleeding) among users of Mirena after use of UPA or placebo
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Endometrial control
Description
Endometrial thickness
Time Frame
Three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Bahamondes, Md
Phone
55 19 32892856
Ext
209
Email
bahamond@caism.unicamp.br
Facility Information:
Facility Name
University of Campinas
City
Campinas
State/Province
SP
ZIP/Postal Code
13083888
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Bahamondes, Md
Phone
55 19 32892856
Ext
209
Email
bahamond@caism.unicamp.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31777949
Citation
Fava M, Peloggia A, Baccaro LF, Castro S, Carvalho N, Bahamondes L. A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system. Int J Gynaecol Obstet. 2020 Apr;149(1):10-15. doi: 10.1002/ijgo.13068. Epub 2019 Dec 11.
Results Reference
derived

Learn more about this trial

Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

We'll reach out to this number within 24 hrs