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

Sponsor

Uteron Pharma S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01695902

Collaborator

(none)

280

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heavy Menstrual Bleeding	Drug: Levosert-20 Drug: Mirena	Phase 3

Study Design

Study Type:

Interventional

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 :

Dec 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

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

Outcome Measures

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 [1 year]

Secondary Outcome Measures

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

Other Outcome Measures

Change from baseline to year 1/year 3 in weight in the 2 treatment groups [up to three years]
Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups [up to three years]
Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups [up to three years]
Occurrence in the 2 treatment groups of evaluable untoward drug reactions [up to three years]
Contraception level and contraceptive effect in the 2 treatment groups [up to three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Uteron Pharma S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Uteron Pharma S.A.

ClinicalTrials.gov Identifier:

NCT01695902

Other Study ID Numbers:

2007-001564-77

First Posted:

Sep 28, 2012

Last Update Posted:

Sep 28, 2012

Last Verified:

Sep 1, 2012

Additional relevant MeSH terms:

Menorrhagia

Hemorrhage

Levonorgestrel

Study Results

No Results Posted as of Sep 28, 2012