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

NCT ID: NCT01695902

Last Updated: 2012-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-09-30

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.

Conditions

Heavy Menstrual Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Levosert-20

Intervention Type: DRUG

Mirena®

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

Group Type: ACTIVE_COMPARATOR

Mirena

Intervention Type: DRUG

Interventions

Levosert-20

Intervention Type: DRUG

Mirena

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uteron Pharma S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2007-001564-77

Identifier Type: -

Identifier Source: org_study_id