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

Status unconfirmed · Phase 4

Conditions studied: Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea

In brief

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.

Key facts

Study ID: NCT01391052
Run by: Scott and White Hospital & Clinic
People needed: 80
Starts: 2011-01-01
Expected to finish: 2013-01-01
Last updated by the study team: 2011-07-11

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

You must be between 18-45 years old
You have Heavy Periods

You may not qualify if…

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

Where it is running

Scott and White Hospital and Clinic — Temple, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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