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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This study will examine whether or not pretreatment with oral norethindrone acetate prior to the insertion of a hormonal intrauterine device will affect post-insertional uterine bleeding. The subjects enrolling in the study will have documented heavy menstrual bleeding (HMB) and desire the levonorgestrel intrauterine system (LNG IUS) (Mirena®, Bayer, Inc. Pittsburgh, PA) for symptomatic relief. HMB for this study is defined as heavy bleeding at regular intervals at least 20-40 days apart. Subjects will be randomized to one of two groups. One group will receive norethindrone acetate for two consecutive months prior to LNG IUS insertion while the other group will proceed with direct insertion of the LNG IUS with no hormonal pre-treatment. Subjects will be followed for a period of 180 days post LNG IUS insertion. Bleeding patterns will be recorded daily.

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

Conditions
-----------------
Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea

Intervention / Treatment
-----------------
* Drug: Norethindrone acetate pretreatment
* Other: No pretreatment


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Norethindrone acetate pretreatment<br>This arm will receive two cycles of norethindrone acetate before LVN IUS insertion. | Drug: Norethindrone acetate pretreatment<br>* 5 mg tablets, three times a day for 21 days for 2 menstrual cycles.<br>* Other names: Aygestin;|
| Other: No pretreatment<br>LVN IUS is placed without norethindrone acetate pretreatment. | Other: No pretreatment<br>* LVN IUS is placed withour Norethindrone acetate pretreatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of bleeding days | Number of days on study calendars with menstrual flow | up to 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menorrhagia Questionnaire | Patients will assess the impact of their menstrual bleeding on their lifestyle. | up to 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrauterine system, reproductive age, menstrual bleeding