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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695902
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):
Uteron Pharma S.A.

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.

Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Drug: Levosert-20 Drug: Mirena Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : December 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Levosert-20
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.
Drug: Levosert-20
Active Comparator: Mirena®
Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG.
Drug: Mirena

Primary Outcome Measures :
  1. 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 Measures :
  1. Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups [ Time Frame: up to three years ]
  2. Comparison of the residual LNG level in the IUS in the 2 treatment groups [ Time Frame: up to three years ]
  3. Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period) [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Change from baseline to year 1/year 3 in weight in the 2 treatment groups [ Time Frame: up to three years ]
  2. Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups [ Time Frame: up to three years ]
  3. Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups [ Time Frame: up to three years ]
  4. Occurrence in the 2 treatment groups of evaluable untoward drug reactions [ Time Frame: up to three years ]
  5. Contraception level and contraceptive effect in the 2 treatment groups [ Time Frame: up to three years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Responsible Party: Uteron Pharma S.A. Identifier: NCT01695902     History of Changes
Other Study ID Numbers: 2007-001564-77
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral