The objective of this double blind placebo-controlled trial is to investigate the effect of Aspirin on estradiol level in post menopausal women. A total of 40 post menopausal women who meet the eligibility criteria will be recruited and after signing the informed consent randomly assigned to receive aspirin or placebo for 6 weeks. Estradiol, SHBG, and testosterone level at the baseline and the end of the study period measured by ELISA method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012195397N1
Registration date:2011-01-03, 1389/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-03, 1389/10/13
Registrant information
Name
Shalaleh Eivazi Adli
Name of organization / entity
Azad University, Pharmacy branch
Country
Iran (Islamic Republic of)
Phone
+98 41 1332 3155
Email address
sh_adli@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-09-01, 1389/06/10
Expected recruitment end date
2011-08-02, 1390/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aspirin on Estradiol level in Post menopausal women
Public title
Effect of Aspirin on Estradiol level in Post menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 45-80 years, not using NSAID drugs during past 3 months, not having menstruation cycle during the past 12 months, bilateral oophorectomy, hysterectomy without the bilateral oophorectomy with age more than 56 for smokers and age more than 54 years old for non-smokers, not using sexual hormones during the past 3 months
Exclusion criteria:Taking NSAIDS or another inflammatory drugs, Inflammatory diseases, consuming of drugs that can alter the estradiol level for instance: inhibitor's aromotase enzyme, women who are candidate for surgery during the following 2-3 months, not willing to participate
Age
From 45 years old to 85 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for research, Tehran University of Medical Sciences
Street address
Central organization of Tehran University of Medical Sciences, Ghods avenue, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2010-10-03, 1389/07/11
Ethics committee reference number
10845-33-02-89
Health conditions studied
1
Description of health condition studied
sexual hormone
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Estradiol
Timepoint
6 weeks
Method of measurement
ELISA
Secondary outcomes
1
Description
SHBG (sex Hormone Binding Glubolin)
Timepoint
6 weeks
Method of measurement
ELISA
2
Description
Testestrone
Timepoint
6 weeks
Method of measurement
ELISA
Intervention groups
1
Description
100 milligram Aspirin daily for 6 weeks
Category
Treatment - Drugs
2
Description
One Placebo capsule daily for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vive-chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Saeidi
Street address
Central organization of Tehran University of Medical Sciences, Ghods avenue, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vive-chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Mania Radfar
Position
Asistant professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, faculty of pharmacy, 16 Azar avenue
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
radfarma@tums.ac.ir; mania1352@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Mania Radfar
Position
Assistant of professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Faculty of pharmacy, 16 Azar avenue
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
radfarma@tums.ac.ir; mania1352@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azad University, Faculty of pharmacy
Full name of responsible person
Shalaleh Eivazi adli
Position
Other areas of specialty/work
Street address
Yasaman allay, Yakhchal avenue, Shariati street
City
Tehran
Postal code
Phone
Fax
Email
shalale.adli@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)