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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
LVN IUS is placed without norethindrone acetate pretreatment.
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.
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, CCRPfirstname.lastname@example.org|
|United States, Texas|
|Scott and White Hospital and Clinic||Recruiting|
|Temple, Texas, United States, 76508|
|Contact: Wendy M White, CCRP 254-724-8301 email@example.com|
|Principal Investigator: Patricia J Sulak, MD|
|Principal Investigator:||Patricia J Sulak, MD||Scott and White Hospital & Clinic|