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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Scott and White Hospital & Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT01391052
First received: July 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

July 7, 2011
July 7, 2011
January 2011
January 2013   (final data collection date for primary outcome measure)
Total number of bleeding days [ Time Frame: up to 180 days ] [ Designated as safety issue: No ]
Number of days on study calendars with menstrual flow
Same as current
No Changes Posted
Menorrhagia Questionnaire [ Time Frame: up to 180 days ] [ Designated as safety issue: No ]
Patients will assess the impact of their menstrual bleeding on their lifestyle.
Same as current
Not Provided
Not Provided
 
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heavy Menstrual Bleeding
  • Menorrhagia
  • Hypermenorrhea
  • Drug: Norethindrone acetate pretreatment
    5 mg tablets, three times a day for 21 days for 2 menstrual cycles.
    Other Name: Aygestin
  • Other: No pretreatment
    LVN IUS is placed withour Norethindrone acetate pretreatment.
  • Active Comparator: Norethindrone acetate pretreatment
    This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.
    Intervention: Drug: Norethindrone acetate pretreatment
  • No pretreatment
    LVN IUS is placed without norethindrone acetate pretreatment.
    Intervention: Other: No pretreatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact: Wendy M White, CCRP 254-724-8301 wewhite@swmail.sw.org
United States
 
NCT01391052
90378
No
Patricia Sulak, MD/principal investigator, Scott and White Hospital & Clinic
Scott and White Hospital & Clinic
Not Provided
Principal Investigator: Patricia J Sulak, MD Scott and White Hospital & Clinic
Scott and White Hospital & Clinic
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP