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Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding (LVS-20)

Primary Purpose

Heavy Menstrual Bleeding

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levosert-20
Mirena
Sponsored by
Uteron Pharma S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Levosert-20

    Mirena®

    Arm Description

    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.

    Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG.

    Outcomes

    Primary Outcome Measures

    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 Measures

    Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups
    Comparison 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)

    Full Information

    First Posted
    September 27, 2012
    Last Updated
    September 27, 2012
    Sponsor
    Uteron Pharma S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01695902
    Brief Title
    Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding
    Acronym
    LVS-20
    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

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uteron Pharma S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heavy Menstrual Bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    280 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levosert-20
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Mirena®
    Arm Type
    Active Comparator
    Arm Description
    Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG.
    Intervention Type
    Drug
    Intervention Name(s)
    Levosert-20
    Intervention Type
    Drug
    Intervention Name(s)
    Mirena
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups
    Time Frame
    up to three years
    Title
    Comparison of the residual LNG level in the IUS in the 2 treatment groups
    Time Frame
    up to three years
    Title
    Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period)
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Change from baseline to year 1/year 3 in weight in the 2 treatment groups
    Time Frame
    up to three years
    Title
    Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups
    Time Frame
    up to three years
    Title
    Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups
    Time Frame
    up to three years
    Title
    Occurrence in the 2 treatment groups of evaluable untoward drug reactions
    Time Frame
    up to three years
    Title
    Contraception level and contraceptive effect in the 2 treatment groups
    Time Frame
    up to three years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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