Heavy Menstrual Bleeding, Hypermenorrhea, Menorrhagia
Conditions
Keywords
Intrauterine system, reproductive age, menstrual bleeding
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.
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.
Interventions
DRUGNorethindrone acetate pretreatment
5 mg tablets, three times a day for 21 days for 2 menstrual cycles.
OTHERNo pretreatment
LVN IUS is placed withour Norethindrone acetate pretreatment.
Sponsors
Scott and White Hospital & Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of bleeding days | up to 180 days | Number of days on study calendars with menstrual flow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menorrhagia Questionnaire | up to 180 days | Patients will assess the impact of their menstrual bleeding on their lifestyle. |
Countries
United States
Contacts
Primary ContactWendy M White, CCRP
Outcome results
None listed