Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding (LVS-20)
The primary objective of this study was to compare the efficacy of Test Product (Levosert) vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia.
The secondary objectives includes physical and gynaecological examinations, vital signs, clinical laboratory tests including hemoglobin and ferritin measurements, body weight and spontaneously reported adverse events were analysed and compared between Levosert and Mirena® treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various periods of time. The residual amounts of LNG in the devices were finally measured after withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were compared between the two treatment groups. Contraceptive effect of Levosert was estimated by Pearl Index.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Multiple Center, Randomised, Parallel Group, Single-blind Clinical Trial, to Assess the Therapeutic Equivalence in Terms of Efficacy and Safety of Test Product (Levosert) and Reference Product (Mirena®) in Patients With Menorrhagia - Phase III (Therapeutic Equivalence).|
- Mean change from baseline to Year 1 in the mean menstrual blood loss volume measured using the modified Wyatt pictogram in the two treatment groups [ Time Frame: 1 year ]
- Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups [ Time Frame: up to three years ]
- Comparison of the residual LNG level in the IUS in the 2 treatment groups [ Time Frame: up to three years ]
- Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period) [ Time Frame: 1 year ]
- Change from baseline to year 1/year 3 in weight in the 2 treatment groups [ Time Frame: up to three years ]
- Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups [ Time Frame: up to three years ]
- Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups [ Time Frame: up to three years ]
- Occurrence in the 2 treatment groups of evaluable untoward drug reactions [ Time Frame: up to three years ]
- Contraception level and contraceptive effect in the 2 treatment groups [ Time Frame: up to three years ]
|Study Start Date:||December 2007|
|Study Completion Date:||September 2011|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Levosert is a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG in a cylindrical-shaped reservoir. The reservoir is mounted on the vertical arm of a T-shaped plastic frame and is covered with a release rate controlling membrane.
Active Comparator: Mirena®
Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG.
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