Heavy Menstrual Bleeding | Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Heavy Menstrual Bleeding research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Heavy Menstrual Bleeding
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Norethindrone acetate pretreatment5 mg tablets, three times a day for 21 days for 2 menstrual cycles.
Other:No pretreatmentLVN IUS is placed withour Norethindrone acetate pretreatment.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Norethindrone acetate pretreatmentThis arm will receive two cycles of norethindrone acetate before LVN IUS insertion.
No pretreatmentLVN IUS is placed without norethindrone acetate pretreatment.
Start Date: January 2011
Completed Date: January 2013
Phase: Phase 4
Primary Outcome: Total number of bleeding days
Secondary Outcome: Menorrhagia Questionnaire
Study sponsors, principal investigator, and references
Principal Investigator: Patricia J Sulak, MD