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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2011 by Scott and White Hospital & Clinic.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Scott and White Hospital & Clinic

ClinicalTrials.gov Identifier:

NCT01391052

First received: July 7, 2011

Last updated: NA

Last verified: January 2011

History: No changes posted

Purpose

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	Intervention	Phase
Heavy Menstrual Bleeding Menorrhagia Hypermenorrhea	Drug: Norethindrone acetate pretreatment Other: No pretreatment	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Menstruation

Drug Information available for: Norethindrone acetate Norethindrone Levonorgestrel

U.S. FDA Resources

Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	80
Study Start Date:	January 2011
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Aygestin
No pretreatment LVN IUS is placed without norethindrone acetate pretreatment.	Other: No pretreatment LVN IUS is placed withour Norethindrone acetate pretreatment.

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


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391052

Contacts


Contact: Wendy M White, CCRP	254-724-8301	wewhite@swmail.sw.org

Locations


United States, Texas
Scott and White Hospital and Clinic	Recruiting
Temple, Texas, United States, 76508
Contact: Wendy M White, CCRP 254-724-8301 wewhite@swmail.sw.org
Principal Investigator: Patricia J Sulak, MD

Sponsors and Collaborators

Scott and White Hospital & Clinic

Investigators


Principal Investigator:	Patricia J Sulak, MD	Scott and White Hospital & Clinic

More Information


Responsible Party:	Patricia Sulak, MD/principal investigator, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:	NCT01391052 History of Changes
Other Study ID Numbers:	90378
Study First Received:	July 7, 2011
Last Updated:	July 7, 2011

Keywords provided by Scott and White Hospital & Clinic:


Intrauterine system reproductive age menstrual bleeding

Additional relevant MeSH terms:


Hemorrhage Menorrhagia Pathologic Processes Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances Levonorgestrel	Norethindrone Norethindrone acetate Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral

ClinicalTrials.gov processed this record on September 20, 2017

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