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

Purpose

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	Intervention	Phase
Heavy Menstrual Bleeding	Drug: Levosert-20 Drug: Mirena	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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).

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Further study details as provided by Uteron Pharma S.A.:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups [ Time Frame: up to three years ] [ Designated as safety issue: No ]
Comparison of the residual LNG level in the IUS in the 2 treatment groups [ Time Frame: up to three years ] [ Designated as safety issue: No ]
Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:

Change from baseline to year 1/year 3 in weight in the 2 treatment groups [ Time Frame: up to three years ] [ Designated as safety issue: No ]
Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups [ Time Frame: up to three years ] [ Designated as safety issue: No ]
Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups [ Time Frame: up to three years ] [ Designated as safety issue: No ]
Occurrence in the 2 treatment groups of evaluable untoward drug reactions [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
Contraception level and contraceptive effect in the 2 treatment groups [ Time Frame: up to three years ] [ Designated as safety issue: No ]

Enrollment:	280
Study Start Date:	December 2007
Study Completion Date:	September 2011
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Uteron Pharma S.A.
ClinicalTrials.gov Identifier:	NCT01695902 History of Changes
Other Study ID Numbers:	2007-001564-77
Study First Received:	September 27, 2012
Last Updated:	September 27, 2012
Health Authority:	Romania: National Agency for Medicines and Medical Devices

Additional relevant MeSH terms:

Menstruation Disturbances
Hemorrhage
Menorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Levonorgestrel

Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 16, 2013

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