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

Scott and White Hospital & Clinic

Status and phase: Unknown; Phase 4

Conditions: Hypermenorrhea; Menorrhagia; Heavy Menstrual Bleeding

Treatments: Drug: Norethindrone acetate pretreatment; Other: No pretreatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01391052

90378

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Norethindrone acetate pretreatment

Active Comparator group

Description:

This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.

Treatment:

Drug: Norethindrone acetate pretreatment

No pretreatment

Other group

Description:

LVN IUS is placed without norethindrone acetate pretreatment.

Treatment:

Other: No pretreatment