Stopping Heavy Periods Project
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 51 |
| Updated: | 10/19/2018 |
| Start Date: | February 2013 |
| End Date: | December 2019 |
| Contact: | Mindy Marshall, MS |
| Email: | mamarshall@wihri.org |
| Phone: | 401-274-1122 |
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.
(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
1
site
Providence, Rhode Island 02905
Principal Investigator: Kristen A. Matteson, MD, MPH
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