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Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding (Mirena IUD)
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.
Details
| Lead sponsor | Scott and White Hospital & Clinic |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 80 |
| Start date | 2011-01 |
| Completion | 2013-01 |
Conditions
- Heavy Menstrual Bleeding
- Menorrhagia
- Hypermenorrhea
Interventions
- Norethindrone acetate pretreatment
- No pretreatment
Primary outcomes
- Total number of bleeding days — up to 180 days
Number of days on study calendars with menstrual flow
Countries
United States