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Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses (SHiPP)
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.
Details
| Lead sponsor | Women and Infants Hospital of Rhode Island |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 59 |
| Start date | 2013-02 |
| Completion | 2021-12-31 |
Conditions
- Abnormal Uterine Bleeding
- Abnormal Uterine Bleeding, Ovulatory Dysfunction
- Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
Interventions
- Levonorgestrel intrauterine system
- Combined oral contraceptives
Primary outcomes
- Menstrual Bleeding Questionnaire — Completed 5 times over a one year time period
We will measure bleeding-specific quality of life using the Menstrual Bleeding Questionnaire (MBQ), a validated tool to assess bleeding-related quality of life, which is the most important outcome for patients and for clinicians treating this symptom. We will measure MBQ score at randomization, and at 6 weeks, 3 month, 6 months, and 12 months post-randomization for both groups
Countries
United States