Clinical Trial Results:
A multicenter, multinational, randomized, parallel group, placebo-controlled, double-blind study to evaluate efficacy and safety of a food supplement containing 80 mg soy isoflavones ZAVITAL in the control of climacteric syndrome in postmenopausal women
|
Summary
|
|
EudraCT number |
2006-000191-32 |
Trial protocol |
IT |
Global end of trial date |
28 May 2008
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Apr 2016
|
First version publication date |
08 Nov 2014
|
Other versions |
|
Summary report(s) |
Clinical Study Report Synopsis 7153L02 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
7153L02
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Zambon SpA
|
||
Sponsor organisation address |
via Lillo del Duca 10, Bresso, Italy, 20091
|
||
Public contact |
Isabella Salerio, Medical Affairs, R&D, +39 02665241,
|
||
Scientific contact |
Isabella Salerio, Medical Affairs, R&D, +39 02665241,
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Sep 2008
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
28 May 2008
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
28 May 2008
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To show superiority of a 12 week treatment with Zavital over placebo in reduction of frequency of hot flushes in post-menopausal women
|
||
Protection of trial subjects |
Not applicable
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Oct 2006
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Italy: 172
|
||
Country: Number of subjects enrolled |
Romania: 215
|
||
Worldwide total number of subjects |
387
|
||
EEA total number of subjects |
387
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
387
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||||||||
|
Recruitment
|
||||||||||||||||
Recruitment details |
subjects were recruited at Gynecological Clinics from October 2006 to March 2008 in Italy and Romania. | |||||||||||||||
|
Pre-assignment
|
||||||||||||||||
Screening details |
After signing the Informed Consent (visit 1), subjects entered a two week run-in period and, if compliant with protocol criteria, then they were randomized (visit 2) to either isoflavones or placebo treatment group for a total of 12 weeks | |||||||||||||||
|
Period 1
|
||||||||||||||||
Period 1 title |
treatment period (overall period)
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||
Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||||||||
Blinding implementation details |
identical packaging and labelling of the two compounds
|
|||||||||||||||
|
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
|
Arm title
|
Zavital treatment | |||||||||||||||
Arm description |
active treatment for 12 weeks | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
soy isoflavones
|
|||||||||||||||
Investigational medicinal product code |
7153
|
|||||||||||||||
Other name |
Zavital
|
|||||||||||||||
Pharmaceutical forms |
Tablet
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
60 mg once a day
|
|||||||||||||||
|
Arm title
|
Placebo | |||||||||||||||
Arm description |
one tablet of placebo | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
soy isoflavones
|
|||||||||||||||
Investigational medicinal product code |
7153
|
|||||||||||||||
Other name |
Zavital
|
|||||||||||||||
Pharmaceutical forms |
Tablet
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
placebo tablet once a day
|
|||||||||||||||
|
||||||||||||||||
| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The subject enrolled were 387, but only 307 randomized. Data are presented on 307 randomized subjects. |
||||||||||||||||
|
||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||
Reporting group title |
treatment period
|
|||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Zavital treatment
|
||
Reporting group description |
active treatment for 12 weeks | ||
Reporting group title |
Placebo
|
||
Reporting group description |
one tablet of placebo | ||
Subject analysis set title |
Full Analysis Set
|
||
Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The Full Analysis Set (FAS) had to include any randomised and treated patient for whom at least one post-baseline primary efficacy assessment was recorded. For primary efficacy assessment is requested by the mean number of hot flushes computed on at least 4 valid measurements out of 7 in the last week before the visit
|
||
|
||||||||||
End point title |
mean number of daily hot flushes | |||||||||
End point description |
The primary efficacy endpoint was the change from baseline in the mean daily frequency of moderate and severe hot flushes
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
during the last 7 days on patient’s diary prior to visit of mid-treatment (6th week), first of all, and secondly at the end-of treatment (12th week).
|
|||||||||
|
||||||||||
Statistical analysis title |
Primary analysis on mean daily hot flushes | |||||||||
Statistical analysis description |
The primary endpoint was to be compared between 80 mg isoflavones and placebo using a fixed-effects analysis of covariance (ANCOVA) model with treatment and centre as fixed factors and baseline value as a covariate; type III sum of squares was planned to be used. The treatments mean difference and its 95% confidence interval was to be estimated on the basis of this model.
The possible existence of a centre effect and its implications was to be investigated. The treatment by centre interaction h
|
|||||||||
Comparison groups |
Zavital treatment v Placebo
|
|||||||||
Number of subjects included in analysis |
287
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
ANOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
-0.36
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-1.23 | |||||||||
upper limit |
0.51 | |||||||||
Variability estimate |
Standard deviation
|
|||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
from signature of informed consent to end of study (Visit 4)
|
||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
safety population
|
||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: the list of non-serious AE is available in the Clinical Study Report |
|||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
