Stopping Heavy Periods Project — SHiPP  

Abnormal Uterine Bleeding Clinical Trial

Official title: Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02002260
• Study type: Interventional
• Source: Women and Infants Hospital of Rhode Island
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2013
• Completion date: December 31, 2021