Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

NCT03186586 | Unknown Phase 4

• 1 other identifier: CEMICAMP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Menstrual Bleeding; Abnormal Bleeding

Keywords

Heavy Menstrual Bleeding; Levonorgestrel relesing intrauterine system

Outcome Measures

Primary Outcomes (1)

• Uterine bleeding control (stop bleeding)

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

  Three months

Secondary Outcomes (1)

• Endometrial control

  Three months

Study Arms (2)

Ulipristal acetate 5mg/day/five days

EXPERIMENTAL

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

Placebo 1 pill/day/five days

PLACEBO COMPARATOR

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

Interventions

Ulipristal acetate DRUG

5mg/day/five days

Ulipristal acetate 5mg/day/five days

Placebo DRUG

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

Placebo 1 pill/day/five days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13083888, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 31777949 DERIVED

MeSH Terms

Conditions

Menorrhagia; Hemostatic Disorders

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Luis Bahamondes, Md

CONTACT

55 19 32892856; bahamond@caism.unicamp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gynecology

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: June 14, 2017
• Study Start: July 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)