Phase 3 N=165 Randomized Treatment

Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

Menorrhagia

Bottom Line

View on ClinicalTrials.gov: NCT00360490 ↗

Enrolled (actual)

165

Serious AEs

0.6%

Results posted

Nov 2009

Primary outcome: Primary: The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) — -128.78; -17.7 milliliter (mL) — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Levonorgestrel IUS (Mirena, BAY86-5028) (Drug); Medroxyprogesterone acetate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)	-128.78; -17.7	<0.001 sig
PRIMARY Percentage of Patients With Successful Treatment	84.8; 22.2	<0.001 sig
SECONDARY Percent Change From Baseline MBL to End of Study MBL (Cycle 6)	-70.75; -21.54	<0.001 sig
SECONDARY Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)	-115.13; -3.15	<0.001 sig
SECONDARY Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)	-61.71; -11.11	<0.001 sig
SECONDARY Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group	97.53; 95.06; 93.83; 92.59; 91.36; 90.12	—
SECONDARY Total Number of Bleeding Days	5.64; 5.64; 10.23; 5.17; 7.88; 5.15	—
SECONDARY Total Number of Spotting and Bleeding Days	6.30; 6.80; 19.70; 6.65; 17.46; 7.46	—
SECONDARY Total Number of Spotting Days	1.23; 1.84; 9.47; 1.48; 9.58; 2.31	—
SECONDARY Total Number of Bleeding Episodes	1.01; 1.03; 1.75; 0.98; 0.88; 1.01	—
SECONDARY Percent Change in Hemoglobin	3.82; 1.65; 3.28; 0.83; 7.50; 1.87	—
SECONDARY Percent Change in Hematocrit	4.9; 0.0; 2.4; 0.0; 5.4; 0.0	—
SECONDARY Percent Change in Serum Ferritin	13.8; 0.0; 48.3; 16.7; 68.8; 14.3	—
SECONDARY Percentage of Patients With Improvement in the Investigator Global Assessment Scale	94.7; 71.2; 93.6; 61.0	—
SECONDARY Percentage of Patients With Improvement in the Patients Overall Assessment Scale	93.3; 74.0; 93.6; 67.1	—

Summary

The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Eligibility Criteria

Inclusion Criteria

Women who have >/= 80 mL blood loss during their menstrual cycles and desire contraception

Exclusion Criteria

Post menopausal menstrual cycle 35 days
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00360490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.