the aim of the study was to assess the safety and efficacy of Fractional co2 VS vaginal conjugated estrogen as a standard treatment of vulvovaginal atrophy in postmenopausal women
inclusion criteria:
1. women's between 45-65 age suffering from Amenorrhea since 24 months
2. women's who diagnosed vaginally atrophy in clinical examination
3. women's who have sexual contract
exclusion criteria:
1. women who treated with systemic estrogen since 6 months ago
2. history of cancer
3. pathologic change in the cervical Pap smear
4.Renal or liver failure
5. women taking estrogen therapy in past history
6. Radiation therapy of the vagina
7. vulvovaginitis
8.History of psychotropic drug or opium use
demographic data including age, education level, Body Mass Index, smoking history, previous live births, sexual activity, the history and duration of previous hormone replacement therapy will be recorded.
in this Randomised Clinical Trial, postmenopausal women with vaginal atrophy will be referred to the Emam Khomeini Hospital gynecologic clinic in Ahvaz, assessed by an expert gynecologist. a total of 130 patient will be enrolled in this study and randomly divided into two groups: receiving either " Fractional co2 laser " or "vaginal conjugated estrogen" for the treatment of vulvovaginal atrophy. The vulvovaginal atrophy symptom of patients will be assessed in the first day of treatment and 12 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050433817N1
Registration date:2017-06-08, 1396/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
saadat Hajatzadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5411
Email address
hajatzadeh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of fractional co2 vs vaginal conjugated estrogen in postmenopausal women diagnosed as having vulvovaginal atrophy
Public title
Laser vs vaginal conjugated estrogen in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
(inclusion criteria: women's between 45-65 age suffering from Amenorrhea since 24 months; women's who diagnosed vaginally atrophy in clinical examination; women's who have sexual contract)
(exclusion criteria: women who treated with systemic estrogen since 6 months ago; history of cancer; pathologic change in the cervical Pap smear; Renal or liver failure; women taking estrogen therapy in past history; Radiation therapy of the vagina; vulvovaginitis; History of psychotropic drug or opium use)
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
room 4, Ground Floor, Department of Development Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
1579461357
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.ajums.REC.1395.670
Health conditions studied
1
Description of health condition studied
vulvovaginal atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
vulvovaginal atrophy symptoms
Timepoint
at base line (day 0), 12 weeks post treatment
Method of measurement
visual analog scale measurement
Secondary outcomes
1
Description
Adverse events
Timepoint
at baseline ( day 0), 12 weeks post treatment
Method of measurement
according to patient history
2
Description
Female Sexual Function Index
Timepoint
at baseline ( day 0), 12 weeks post treatment
Method of measurement
according to Female Sexual Function Index
3
Description
Sexual satisfaction
Timepoint
at baseline ( day 0), 12 weeks post treatment
Method of measurement
visual analog scale measurement
Intervention groups
1
Description
The Fractional CO2 laser with Angela trademark( Fractional CO2 LASER MX-7000 smart pulse) ,
the treatment will be used for 3 Sessions and 4 weeks intervals
Category
Treatment - Other
2
Description
topical conjugated estrogen (0.625 mg conjugated equine estrogens per 1 g vaginal cream; n = 30) administered once daily for two weeks, then twice weekly for 8 weeks.