The purpose of this study was to investigate the effect of laser fractional carbon dioxide (CO2) and vaginal cream Premarin on the improvement of sexual function in postmenopausal women.
Design
A two-group clinical trial is in the third phase. Postmenopausal women were selected with the inclusion criteria. Samples were randomly divided into two groups of parallel treatment (n = 25) and control group (n = 25) based on random blocks of size 4 and using sealed envelopes containing cards containing randomized sequences were divided.
Settings and conduct
The present study was a clinical trial of two groups that was performed at the Pelvic Disorders Clinic of Imam Khomeini Hospital affiliated to Tehran University of Medical Sciences. The population under study was the postmenopausal women referring to the clinic.
Participants/Inclusion and exclusion criteria
Postmenopausal women aged 45-65 years, at least one year after of their last menstruation, were entered the study with the sexual activity ،single-sex and monogamy, having dyspareunia and sexual problems associated with vulvovaginal atrophy. Use of any topical or systemic hormone therapy within 6 months before entering the study and use of vaginal lubrication for 30 days before entering the study; Acute or chronic urinary tract infections; Acute Genital Herpes (Herpes Candida); Stage 2 Or more of prolapse, having psychiatric disorders and smoking was a condition for not entering the study.
Intervention groups
Intervention group 1: A group of postmenopausal women treated with co2 laser for three months, once a month.
Intervention group 2 (control): A group of postmenopausal women who used the vaginal cream as one-third of the applicator three nights a week.
Main outcome variables
The main outcomes included examining the dimensions of sexual desire, lubrication, orgasm, satisfaction, and disparity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160916029835N3
Registration date:2018-10-06, 1397/07/14
Registration timing:retrospective
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
tahereh khalili borujeni
Name of organization / entity
tehran university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
t-khalilib@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-08-07, 1396/05/16
Expected recruitment end date
2017-11-07, 1396/08/16
Actual recruitment start date
2017-08-07, 1396/05/16
Actual recruitment end date
2017-11-07, 1396/08/16
Trial completion date
2017-11-07, 1396/08/16
Scientific title
Comparative Study of the effect of CO2 Fractional Laser and Vaginal Cream Premarine on improving sexual function in postmenopausal women
Public title
Comparative Study of the effect of CO2 Fractional Laser and Vaginal Cream Premarine on improving sexual function in Postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having sexual activity
Having single sex and monogamy
The age range of 65-45 years
Having Disparony and Sexual Complications associated with Vaginal Atrophy
Women who have passed at least one year of their last menstrual period or women with high FSH 40
The presence of symptoms of vaginal atrophy
There is a sexual problem during intercourse
Consent to participate in the study
Exclusion criteria:
Use of any type of topical or systemic hormonal alternative therapist for 6 months before entering the study
Use of vaginal lubrication within 30 days before entering the study
Acute or chronic urinary tract infection
Acute Genital Infections (Herpes Candida)
Psychiatric disorders interact with the completion of the informed consent form
Smoking
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was a block size of 4, which was a randomized sealed envelope, each of which was randomly recorded on a card, and the cards were inserted into the envelopes respectively.
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
Ethics Committee of Tehran University of Medical Sciences
Street address
6th floor, Ghods St, Keshavarz Blvd.Central Organization of the University, Deputy of Research and Technology of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14145
Approval date
2017-08-07, 1396/05/16
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.2552
Health conditions studied
1
Description of health condition studied
Sexual dysfunction in postmenopausal women
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
Sexual Function
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Sexual function Questionnaire
Secondary outcomes
1
Description
Improve disparony
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Questionnaire
2
Description
Improve orgasms
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Questionnaire
3
Description
Improve desire
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Vaginal cream premarine one-third of the oplicator three nights a week for twelve weeks
Category
Treatment - Drugs
2
Description
Vaginal laser co2 monthly for three months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Tahereh Khalili Borujeni
Street address
Pelvic Clinic,Imam Khoeini Hosital,Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
14145
Phone
+98 21 6119 2271
Email
khalilitahereh@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Karimi
Street address
6th floor, Ghods St, Keshavarz Blvd.Central Organization of the University, Deputy of Research and Technology of Tehran University of Medical Sciences .
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 8163 3698
Email
drkarimi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?