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

Menorrhagia Clinical Trial

— Mirena IUD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01391052
• Other study ID #: 90378
• Status: Recruiting
• Phase: Phase 4
• First received: July 7, 2011
• Last updated: July 7, 2011
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2011
• Source: Scott and White Hospital & Clinic
• Contact: Wendy M White, CCRP
• Phone: 254-724-8301
• Email: wewhite[@]swmail.sw.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Hypermenorrhea
• Menorrhagia

Intervention

Drug:
• Norethindrone acetate pretreatment
5 mg tablets, three times a day for 21 days for 2 menstrual cycles.

Other:
• No pretreatment
LVN IUS is placed withour Norethindrone acetate pretreatment.

Locations

Country	Name	City	State
United States	Scott and White Hospital and Clinic	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Scott and White Hospital & Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of bleeding days	Number of days on study calendars with menstrual flow	up to 180 days	No
Secondary	Menorrhagia Questionnaire	Patients will assess the impact of their menstrual bleeding on their lifestyle.	up to 180 days	No