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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.


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 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)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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


- 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


- 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


- 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

Page last updated: August 23, 2015

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