Heavy Menstrual Bleeding
Conditions
Brief summary
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.
Interventions
DRUGLevosert-20
DRUGMirena
Sponsors
Uteron Pharma S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups | up to three years |
Other
| Measure | Time frame |
|---|---|
| Change from baseline to year 1/year 3 in weight in the 2 treatment groups | up to three years |
| Contraception level and contraceptive effect in the 2 treatment groups | up to three years |
| Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups | up to three years |
| Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups | up to three years |
| Occurrence in the 2 treatment groups of evaluable untoward drug reactions | up to three years |
Outcome results
None listed