Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heavy Menstrual Bleeding Menorrhagia Hypermenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Norethindrone acetate pretreatment

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

Group Type ACTIVE_COMPARATOR

Norethindrone acetate pretreatment

Intervention Type DRUG

5 mg tablets, three times a day for 21 days for 2 menstrual cycles.

No pretreatment

LVN IUS is placed without norethindrone acetate pretreatment.

Group Type OTHER

No pretreatment

Intervention Type OTHER

LVN IUS is placed withour Norethindrone acetate pretreatment.

Interventions

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Norethindrone acetate pretreatment

5 mg tablets, three times a day for 21 days for 2 menstrual cycles.

Intervention Type DRUG

No pretreatment

LVN IUS is placed withour Norethindrone acetate pretreatment.

Intervention Type OTHER

Other Intervention Names

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Aygestin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes