Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT01695902
Status:
COMPLETED
Last Update Posted:
2012-09-28
First Post:
2012-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding
Sponsor:
Uteron Pharma S.A.
Organization:
Study Overview
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).
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LVS-20
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: