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

Primary Purpose

Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Norethindrone acetate pretreatment
No pretreatment
Sponsored by
Scott and White Hospital & Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding focused on measuring Intrauterine system, reproductive age, menstrual bleeding

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Scott and White Hospital and ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Norethindrone acetate pretreatment

No pretreatment

Arm Description

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

LVN IUS is placed without norethindrone acetate pretreatment.

Outcomes

Primary Outcome Measures

Total number of bleeding days
Number of days on study calendars with menstrual flow

Secondary Outcome Measures

Menorrhagia Questionnaire
Patients will assess the impact of their menstrual bleeding on their lifestyle.

Full Information

First Posted
July 7, 2011
Last Updated
July 7, 2011
Sponsor
Scott and White Hospital & Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01391052
Brief Title
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Acronym
Mirena IUD
Official Title
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Scott and White Hospital & Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea
Keywords
Intrauterine system, reproductive age, menstrual bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Norethindrone acetate pretreatment
Arm Type
Active Comparator
Arm Description
This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.
Arm Title
No pretreatment
Arm Type
Other
Arm Description
LVN IUS is placed without norethindrone acetate pretreatment.
Intervention Type
Drug
Intervention Name(s)
Norethindrone acetate pretreatment
Other Intervention Name(s)
Aygestin
Intervention Description
5 mg tablets, three times a day for 21 days for 2 menstrual cycles.
Intervention Type
Other
Intervention Name(s)
No pretreatment
Intervention Description
LVN IUS is placed withour Norethindrone acetate pretreatment.
Primary Outcome Measure Information:
Title
Total number of bleeding days
Description
Number of days on study calendars with menstrual flow
Time Frame
up to 180 days
Secondary Outcome Measure Information:
Title
Menorrhagia Questionnaire
Description
Patients will assess the impact of their menstrual bleeding on their lifestyle.
Time Frame
up to 180 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy M White, CCRP
Phone
254-724-8301
Email
wewhite@swmail.sw.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia J Sulak, MD
Organizational Affiliation
Scott and White Hospital & Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scott and White Hospital and Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy M White, CCRP
Phone
254-724-8301
Email
wewhite@swmail.sw.org
First Name & Middle Initial & Last Name & Degree
Patricia J Sulak, MD

12. IPD Sharing Statement

Learn more about this trial

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

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