This study is a clinical trial to compare vitamin E vaginal suppository with conjugated estrogen vaginal cream on the treatment of atrophic vaginitis in menopausal women. Inclusion criteria consisted of: married, sexually active women aged 40-65 years old; amenorrhea for at least 12 months; having a normal Pap smear within the past 3 years; clinical atrophy of the vagina through a set of criteria that includes: PH Vagina> 5 and earn a score of 65 or higher (based on a visual analogue scale, VAS) for most bothersome symptoms (MBS) and superficial cells equal or less than 5% and at least two symptoms of Descriptive Assessment Table of Vaginal Mucosa. Exclusion criteria included abnormal vaginal bleeding; hypersensitivity to conjugated estrogen cream; hormone therapy 8 weeks before the study. 60 postmenopausal women with symptoms of vaginal atrophy were randomized in two group to take vaginal suppositories of 100 IU vitamin E (n=30) or 1/8 applicator of conjugated estrogen vaginal cream (n=30) for 12 weeks. The symptoms of vaginal atrophy were evaluated by a Descriptive Assessment of Vaginal Mucosa ; most bothersome symptoms (MBS); vaginal pH and maturation value before and 1, 2, 3 months after therapy will be measured and compared in both the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060913611N1
Registration date:2013-07-14, 1392/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Azam parnan emamverdikhan
Name of organization / entity
School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1341 5848
Email address
parnana901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2014-01-10, 1392/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vitamin E vaginal suppository with conjugated estrogen vaginal cream on the treatment of atrophic vaginitis in menopausal women
Public title
Non-hormonal treatment of vaginal atrophy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 40-65 years old; amenorrhea for at least 12 months, or 6 months after the last menstrual them with FSH> 40; having a normal Pap smear within the past 3 years, or more than 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy; clinical atrophy of the vagina through a set of criteria that includes: PH vagina> 5 and earn a score of 65 or higher (based on a visual analogue scale, VAS) for most bothersome symptoms (MBS) and superficial cells equal or less than 5% and at least two symptoms of Descriptive Assessment Table of Vaginal Mucosa. Exclusion criteria: existing breast or endometrial cancer or suspicion thereof, genital abnormalities; abnormal vaginal bleeding; cardiovascular disease (including coronary heart disease; cerebrovascular disease; thromboembolic disorders); active liver or gallbladder disease; diabetes and blood pressure-lowering drugs; vaginal infection; allergy to estrogen and vitamin E; hormone use during the 8 weeks before the study; the use of 40 to 60 grams phytoestrogens during the day; use of stimuli that can cause chronic itching in the vagina; useing less than 70% of the total number of drug (less than 24 times during the treatment period
Age
From 40 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctors Crossroads
City
Mashhad
Postal code
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
research/911186/1/6
Health conditions studied
1
Description of health condition studied
vaginal atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal Atrophic Vaginitis
Primary outcomes
1
Description
Symptoms of vaginal atrophy
Timepoint
Before intervention, 4, 8 and 12 weeks after intervention
Method of measurement
Description of the vaginal mucosa، vaginal maturation index, the most bothersome symptom of vaginal and vaginal pH
Secondary outcomes
1
Description
Superficial cells in the vagina
Timepoint
Befor the intervention، 4، 8 and 12 weeks after intervention
Method of measurement
Vaginal maturation index
Intervention groups
1
Description
Intervention 2: 12-week treatment period. Conjugated estrogen vaginal cream once daily for 2 weeks، followed by twice weekly administration for a further 10 weeks as a maintenance therapy
Category
Treatment - Drugs
2
Description
Intervention1: 12-week treatment period. Vitamin E vaginal suppositories once daily for 2 weeks ، followed by twice weekly administration for a further 10 weeks as a maintenance therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Womens clinic of Ghaem Hospital
Full name of responsible person
aazam parnan emamverdikhan
Street address
Mashhad، Ghaem Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad Universityof Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad, Vakil Abad Boulevard, University College, School of Pharmacy, Department of Pharmaceutics
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Universityof 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
Mashhad University of Medical Sciences
Full name of responsible person
Aazam Prnan Emamverdikhan
Position
Postgraduate students
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctors Crossroads
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
parnana901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid golmakani
Position
Masters،Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctors Crossroads
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
Golmakanin@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aazam Prnan Emamverdikhan
Position
Postgraduate student
Other areas of specialty/work
Street address
Mashhad, Vakil Abad Boulevard, University College, School of Pharmacy, Department of Pharmaceutics
City
Mashhad
Postal code
Phone
+98 51 1341 5848
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)