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

• ClinicalTrials.gov Identifier: NCT01391052
• Recruitment Status: Unknown
• First Posted: July 11, 2011
• Last Update Posted: July 11, 2011
• Sponsor: Scott and White Hospital & Clinic
• Information provided by: Scott and White Hospital & Clinic

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 (Clinical Trial)
• Estimated 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: January 2011
• Estimated Primary Completion Date: January 2013
• Estimated Study Completion Date: January 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 Name: Aygestin
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 :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• 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

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
• First Posted: July 11, 2011
• Last Update Posted: July 11, 2011
• Last Verified: January 2011

Keywords provided by Scott and White Hospital & Clinic:

Intrauterine system; reproductive age; menstrual bleeding

Additional relevant MeSH terms:

Menorrhagia; Hemorrhage; 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