Clinical trial NCT01391052: Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Official title: Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heavy Menstrual Bleeding
Menorrhagia
Hypermenorrhea
Keywords: Intrauterine system
reproductive age
menstrual bleeding
Lead sponsor: Scott and White Hospital & Clinic
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total number of bleeding days
timeFrame: up to 180 days
Secondary outcomes:
measure: Menorrhagia Questionnaire
timeFrame: up to 180 days
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott and White Hospital and Clinic
state: Texas
Study officials:
affiliation: Scott and White Hospital & Clinic
name: Patricia J Sulak, MD
role: PRINCIPAL_INVESTIGATOR
References: