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

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ClinicalTrials.gov Identifier: NCT01391052
Recruitment Status : Unknown
Verified January 2011 by Scott and White Hospital & Clinic.
Recruitment status was:  Recruiting
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
Scott and White Hospital & Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Menorrhagia Hypermenorrhea Drug: Norethindrone acetate pretreatment Other: No pretreatment Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

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Arms and Interventions
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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 Name: Aygestin
No pretreatment
LVN IUS is placed without norethindrone acetate pretreatment.
 Other: No pretreatment
LVN IUS is placed withour Norethindrone acetate pretreatment.


Outcome Measures
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Primary Outcome Measures :
  1. Total number of bleeding days [ Time Frame: up to 180 days ]
    Number of days on study calendars with menstrual flow


Secondary Outcome Measures :
  1. Menorrhagia Questionnaire [ Time Frame: up to 180 days ]
    Patients will assess the impact of their menstrual bleeding on their lifestyle.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391052


Contacts
Contact: Wendy M White, CCRP 254-724-8301 wewhite@swmail.sw.org

Locations
United States, Texas
Scott and White Hospital and Clinic Recruiting
Temple, Texas, United States, 76508
Contact: Wendy M White, CCRP    254-724-8301    wewhite@swmail.sw.org   
Principal Investigator: Patricia J Sulak, MD         
Sponsors and Collaborators
Scott and White Hospital & Clinic
Investigators
Principal Investigator: Patricia J Sulak, MD Scott and White Hospital & Clinic
More Information
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Responsible Party: Patricia Sulak, MD/principal investigator, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier: NCT01391052     History of Changes
Other Study ID Numbers: 90378
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: January 2011

Keywords provided by Scott and White Hospital & Clinic:
Intrauterine system
reproductive age
menstrual bleeding

Additional relevant MeSH terms:
Hemorrhage
Menorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Levonorgestrel
 Norethindrone
Norethindrone acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral