Stopping Heavy Periods Project

Conditions:Women's Studies
Therapuetic Areas:Reproductive
Age Range:18 - 51
Start Date:February 2013
End Date:December 2019
Contact:Mindy Marshall, MS

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Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses

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 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.

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
We found this trial at
Providence, Rhode Island 02905
Principal Investigator: Kristen A. Matteson, MD, MPH
Providence, RI
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