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Completed

NCT Number: NCT01695902

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

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.

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Key information

Conditions

Heavy Menstrual Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levosert-20

Drug

Mirena

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Uteron Pharma S.A.

Industry

Registry information

Official study 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).

Acronym: LVS-20

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Sep 28, 2012
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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