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

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scott and White Hospital & Clinic
• Treatments: Levonorgestrel; Norethindrone; Norethindrone Acetate

Criteria

Inclusion Criteria:

• You must be between 18-45 years old

• You have Heavy Periods

Exclusion Criteria:

• You are pregnant

• You are currently using hormonal contraception or hormonal therapy

• You have a history of pelvic inflammatory disease (and have not had a normal pregnancy since)

• You had an infected abortion within the last three months

• You have abnormal or cancerous cells of the cervix or uterus

• You have an actine infection in your genital organs

• Known or suspected breast cancer

• Active liver disease or tumors

• Allergy to levonorgestrel or norethindrone

• You currently have deep vein thrombosis, pulmonary embolism, or history of these conditions

• you currently have active or recent (within the past year) arterial thromboembolic disease (such as a stroke or myocardial infarction) these conditions