Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Heavy Menstrual Bleeding

Intervention / Treatment
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* Drug: Levosert-20
* Drug: Mirena


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18 years of age. Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them. Exclusion Criteria: History of endometrial ablation or dilatation and/or curettage within the 3 months prior to screening Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to screening Abnormal liver function or jaundice Renal insufficiency Other hormonal treatment (sexual steroids), Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous myomas of any size, or myometrial myomas > than 3 cm, adenomyosis, atypical hyperplasia, carcinoma) Abnormal uterine morphology Presence of ovarian cyst > 3 cm Lower genital tract infection Current or recurrent PID (present or recurrent pelvis infection (including history of postpartum endometritis, infected miscarriage) during the past 3 months Uncontrolled hypertension Congenital or acquired valvular disease (including corrections with prosthetic valves) Known or suspected pregnancy Known or suspected hormone-dependent tumor BMI > 30 Abnormal Pap smear test or other evidence of cervical/endometrial mancy Unexplained amenorrhea Known hypersensitivity to device material and/or Levonorgestrel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levosert-20<br>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. | Drug: Levosert-20<br> <br> |
| Active Comparator: Mirena®<br>Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG. | Drug: Mirena<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups |  | up to three years | 
| Comparison of the residual LNG level in the IUS in the 2 treatment groups |  | up to three years | 
| Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period) |  | 1 year |