Stopping Heavy Periods Project

N/AUnknownNCT02002260

Women and Infants Hospital of Rhode Island59 enrolled

Overview

This study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for improving quality of life among women who report heavy menstrual bleeding.

This study is designed to be conducted within the context of a patient's standard/usual/typical care from their primary gynecologic care provider. We hypothesize that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related quality of life at 6 months and one year. To test this hypothesis, we plan to enroll 59 women from several sites who present for gynecologic care and self-report heavy menstrual bleeding into a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abnormal Uterine Bleeding Abnormal Uterine Bleeding, Ovulatory Dysfunction Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction

Interventions

Levonorgestrel intrauterine systemDEVICE

Combined oral contraceptivesDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 51 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Self-reported heavy menstrual bleeding * Age 18-51 years * Etiology of heavy menstrual bleeding from either ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E) Exclusion Criteria: * Plan pregnancy in the next year * Menopausal * Currently has a copper IUD in place * History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS

Locations (1)

Gynecologic practices affiliated with Women and Infants Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Menstrual Bleeding Questionnaire

We will measure bleeding-specific quality of life using the Menstrual Bleeding Questionnaire (MBQ), a validated tool to assess bleeding-related quality of life, which is the most important outcome for patients and for clinicians treating this symptom. We will measure MBQ score at randomization, and at 6 weeks, 3 month, 6 months, and 12 months post-randomization for both groups

Time frame: Completed 5 times over a one year time period

Secondary Outcomes

Treatment Failure

The goal of treating heavy menstrual bleeding is to utilize a treatment option that improves patient quality of life and avoids surgical intervention. We will look at treatment failure two different ways. We will determine the overall proportion of participants who discontinued their assigned treatment (opted for no treatment or chose a different treatment option, including surgery) and subset that opted for surgical intervention (endometrial ablation or hysterectomy) during the study period. This information will be recorded by the primary gynecologic provider (physical examination and physician form), by participants (interval health history form), and by the research team (medical record review).

Time frame: Information collected at four time points during a one year period post randomization

Data from ClinicalTrials.gov

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