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

Phase 4

• Conditions: Heavy Menstrual Bleeding; Menorrhagia; Hypermenorrhea
• Interventions: Drug: Norethindrone acetate pretreatment; Other: No pretreatment

• Registration Number: NCT01391052
• Lead Sponsor: Scott and White Hospital & Clinic

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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Last Update Submitted: 2011-07-07
• Study First Posted: 2011-07-11
• Last Update Posted: 2011-07-11
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norethindrone acetate pretreatment	Norethindrone acetate pretreatment	This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.
No pretreatment	No pretreatment	LVN IUS is placed without norethindrone acetate pretreatment.

Primary Outcome Measures

Name	Time	Method
Total number of bleeding days	up to 180 days	Number of days on study calendars with menstrual flow

Secondary Outcome Measures

Name	Time	Method
Menorrhagia Questionnaire	up to 180 days	Patients will assess the impact of their menstrual bleeding on their lifestyle.

Trial Locations

Locations (1)

Scott and White Hospital and Clinic; 🇺🇸 Temple, Texas, United States