The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
Acronyms in the Adverse Event Section: * IUCD Intrauterine Contraceptive Device * MedDRA Medical Dictionary for Regulatory Activities This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.
Time frame: Baseline and up to 6 months
Percentage of Patients With Successful Treatment
End-of-study MBL \< 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.
Time frame: At 6 months
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.
Time frame: Baseline and up to 6 months
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.
Time frame: Baseline and up to 3 months
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
Time frame: Baseline and up to 3 months
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
Time frame: Baseline and up to 6 months
Total Number of Bleeding Days
In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
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Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Carmichael, California, United States
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San Diego, California, United States
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San Diego, California, United States
Unnamed facility
Santa Monica, California, United States
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Torrance, California, United States
Unnamed facility
Littleton, Colorado, United States
Unnamed facility
Boynton Beach, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
...and 44 more locations
Time frame: Baseline and up to 6 months
Total Number of Spotting and Bleeding Days
In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
Time frame: Baseline and up to 6 months
Total Number of Spotting Days
In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
Time frame: Baseline and up to 6 months
Total Number of Bleeding Episodes
A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
Time frame: Baseline and up to 6 months
Percent Change in Hemoglobin
Time frame: Baseline and up to 6 months
Percent Change in Hematocrit
Time frame: Baseline and up to 6 months
Percent Change in Serum Ferritin
Time frame: Baseline and up to 6 months
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'
Time frame: Up to 6 months
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'.
Time frame: Up to 6 months