Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding
Information source: Uteron Pharma S.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heavy Menstrual Bleeding
Intervention: Levosert-20 (Drug); Mirena (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Uteron Pharma S.A.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groupsComparison of the residual LNG level in the IUS in the 2 treatment groups Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: December 2007
Last updated: September 27, 2012
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