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