Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding (Mirena IUD)
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ClinicalTrials.gov Identifier: NCT01391052 |
Recruitment Status : Unknown
Verified January 2011 by Scott and White Hospital & Clinic.
Recruitment status was: Recruiting
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heavy Menstrual Bleeding Menorrhagia Hypermenorrhea | Drug: Norethindrone acetate pretreatment Other: No pretreatment | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Norethindrone acetate pretreatment
This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.
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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.
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Other: No pretreatment
LVN IUS is placed withour Norethindrone acetate pretreatment. |
- Total number of bleeding days [ Time Frame: up to 180 days ]Number of days on study calendars with menstrual flow
- Menorrhagia Questionnaire [ Time Frame: up to 180 days ]Patients will assess the impact of their menstrual bleeding on their lifestyle.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391052
Contact: Wendy M White, CCRP | 254-724-8301 | wewhite@swmail.sw.org |
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 |
Principal Investigator: | Patricia J Sulak, MD | Scott and White Hospital & Clinic |
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 Key Record Dates |
Last Update Posted: | July 11, 2011 |
Last Verified: | January 2011 |
Intrauterine system reproductive age menstrual bleeding |
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 |