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Stopping Heavy Periods Project

Information source: Women and Infants Hospital of Rhode Island
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abnormal Uterine Bleeding; Abnormal Uterine Bleeding, Ovulatory Dysfunction; Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction

Intervention: Levonorgestrel intrauterine system (Device); Combined oral contraceptives (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Women and Infants Hospital of Rhode Island

Official(s) and/or principal investigator(s):
Kristen A Matteson, M.D., M.P.H., Principal Investigator, Affiliation: Women and Infants Hospital

Overall contact:
Tracey Ferreira, Phone: 401-274-1122, Ext: 48553, Email: tfferreira@wihri.org

Summary

This study is a randomized clinical trial comparing the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for treatment of 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 and will be associated with fewer treatment failures and greater cost-effectiveness at one year. To test these hypotheses, we plan to enroll 212 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Menstrual Bleeding Questionnaire

Secondary outcome: Treatment Failure

Eligibility

Minimum age: 18 Years. Maximum age: 51 Years. Gender(s): Female.

Criteria:

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 on COCs or have an IUD in place

- History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS

Locations and Contacts

Tracey Ferreira, Phone: 401-274-1122, Ext: 48553, Email: tfferreira@wihri.org

Gynecologic practices affiliated with Women and Infants Hospital, Providence, Rhode Island 02905, United States; Recruiting
Tracey Ferreira, Email: TFFerreira@wihri.org
Kristen A. Matteson, MD, MPH, Principal Investigator
Melissa A. Clark, PhD, Sub-Investigator
Additional Information

Starting date: February 2013
Last updated: December 4, 2013

Page last updated: August 23, 2015

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