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

Sponsor

Scott and White Hospital & Clinic (Other)

Overall Status

Unknown status

CT.gov ID

NCT01391052

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heavy Menstrual Bleeding Menorrhagia Hypermenorrhea	Drug: Norethindrone acetate pretreatment Other: No pretreatment	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2013

Anticipated Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Norethindrone acetate pretreatment This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.	Drug: Norethindrone acetate pretreatment 5 mg tablets, three times a day for 21 days for 2 menstrual cycles. Other Names: Aygestin
Other: No pretreatment LVN IUS is placed without norethindrone acetate pretreatment.	Other: No pretreatment LVN IUS is placed withour Norethindrone acetate pretreatment.

Arm

Intervention/Treatment

Active Comparator: Norethindrone acetate pretreatment

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

Drug: Norethindrone acetate pretreatment

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

Other Names:

Aygestin

Other: No pretreatment

LVN IUS is placed without norethindrone acetate pretreatment.

Other: No pretreatment

LVN IUS is placed withour Norethindrone acetate pretreatment.

Outcome Measures

Primary Outcome Measures

Total number of bleeding days [up to 180 days]
Number of days on study calendars with menstrual flow

Secondary Outcome Measures

Menorrhagia Questionnaire [up to 180 days]
Patients will assess the impact of their menstrual bleeding on their lifestyle.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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