Clinical trial NCT01695902: Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heavy Menstrual Bleeding
Lead sponsor: Uteron Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2012-09-28
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups
timeFrame: up to three years
measure: Comparison of the residual LNG level in the IUS in the 2 treatment groups
timeFrame: up to three years
measure: Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period)
timeFrame: 1 year
Other outcomes:
measure: Change from baseline to year 1/year 3 in weight in the 2 treatment groups
timeFrame: up to three years
measure: Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups
timeFrame: up to three years
measure: Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups
timeFrame: up to three years
measure: Occurrence in the 2 treatment groups of evaluable untoward drug reactions
timeFrame: up to three years
measure: Contraception level and contraceptive effect in the 2 treatment groups
timeFrame: up to three years
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