drugset / Trial / NCT01391052

Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding

NCT01391052

Phase 4 Unknown 80 enrolled Scott and White Hospital & Clinic
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2011-01
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Norethindrone Unknown 5 mg Oral

Indications