Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Information source: Scott and White Hospital & Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heavy Menstrual Bleeding; Menorrhagia; Hypermenorrhea
Intervention: Norethindrone acetate pretreatment (Drug); No pretreatment (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Scott and White Hospital & Clinic Official(s) and/or principal investigator(s): Patricia J Sulak, MD, Principal Investigator, Affiliation: Scott and White Hospital & Clinic
Overall contact: Wendy M White, CCRP, Phone: 254-724-8301, Email: wewhite@swmail.sw.org
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.
Clinical Details
Official title: Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Total number of bleeding days
Secondary outcome: Menorrhagia Questionnaire
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Wendy M White, CCRP, Phone: 254-724-8301, Email: wewhite@swmail.sw.org
Scott and White Hospital and Clinic, Temple, Texas 76508, United States; Recruiting Wendy M White, CCRP, Phone: 254-724-8301, Email: wewhite@swmail.sw.org Patricia J Sulak, MD, Principal Investigator
Additional Information
Starting date: January 2011
Last updated: July 7, 2011
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