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
About this trial
This is an interventional treatment trial for Heavy Menstrual Bleeding
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
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
NCT ID
NCT01695902
First Posted
September 27, 2012
Last Updated
September 27, 2012
Sponsor
Uteron Pharma S.A.
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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