Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding (Mirena IUD)

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.

Study Overview

• Status: Unknown
• Conditions: Menorrhagia; Heavy Menstrual Bleeding; Hypermenorrhea
• Intervention / Treatment: Drug: Norethindrone acetate pretreatment; Other: No pretreatment

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wendy M White, CCRP; Phone Number: 254-724-8301; Email: wewhite@swmail.sw.org

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Recruiting
      • Scott and White Hospital and Clinic
      • Contact: Wendy M White, CCRP; Phone Number: 254-724-8301; Email: wewhite@swmail.sw.org
      • Principal Investigator: Patricia J Sulak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Scott and White Hospital & Clinic
• Investigators: Principal Investigator: Patricia J Sulak, MD, Scott and White Hospital & Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): July 11, 2011
• Last Update Submitted That Met QC Criteria: July 7, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Intrauterine system; reproductive age; menstrual bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Menstruation Disturbances; Uterine Hemorrhage; Hemorrhage; Menorrhagia; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Norethindrone; Norethindrone Acetate
• Other Study ID Numbers: 90378