NCT02002260

Stopping Heavy Periods Project

Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Levonorgestrel intrauterine system
DRUG	Combined oral contraceptives

Timeline

• Start date: 2013-02-01
• Primary completion: 2019-06-16
• Completion: 2021-12-31
• First posted: 2013-12-05
• Last updated: 2021-08-02

Locations

1 site across 1 country: United States