Objective: Sexual dysfunction is one of the most common problems of women in all age groups, cultural and socioeconomic groups. Menopause and estrogen reductions in the body increase the perceived severity of sexual problems. Sexual dysfunction affects not only personal and marital relationships, but also the quality of sexual life of individuals. Design: This is a double-blind clinical trial. Participants: 100 postmenopausal women and 100 non-menopausal women aged 45-65 and post-menopausal 25-45 years old in Tehran. Setting and conduct: Participants were randomly divided into two groups of drug users and placebo for three months. The instrument used in this study is Gender Equity Standards and Sexual Function Index of Women that is completed and reviewed before and three months after drug intake. Intervention: 100 mg sildenafil tablets and placebo are taken vaginally 1 hour before each sexual intercourse for 3 months. Main outcome measure: Improving female sexual satisfaction and sexual function is the main outcome variable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112015461N1
Registration date:2017-11-07, 1396/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-07, 1396/08/16
Registrant information
Name
Azar Mashhoori Vayghan
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 5778
Email address
azar.mashhoori@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vaginal Sildenafil on Female Sexual Function Index and Sexual Satisfaction, in Premenopause and Postmenopause Women
Public title
Effect of Vaginal Sildenafil on Female Sexual Function Index and Sexual Satisfaction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 45-65 years old in post menopause and 25-45 years old in premenstrual women; Being sexually active; at least 12 month amenorah in post menopause women; no surgical menopause; no hormone replacement therapy; BMI= 19.8-30; no high BP; no drug use;no smoking; no alcohol; no liver; heart; thyroid disease or diabetic; no chronic disease; no cancer or precancerous disease; no vaginal bleeding;no endometrial hyperplasia or polyp; no pelvic radiation.
Age
From 25 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
nothing
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modarres University
Street address
Nasr bridge, Jalale Ale Ahmad.
City
Tehran
Postal code
14445-331
Approval date
2013-12-11, 1392/09/20
Ethics committee reference number
552/4999
Health conditions studied
1
Description of health condition studied
Female Sexual Dysfunction and Satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improvement of female sexual satisfaction and sexual function
Timepoint
Three months after the intervention
Method of measurement
Complete Sexual Function Questionnaire (FSFI) and Sexual Satisfaction (ISS) before and after intervention
Secondary outcomes
1
Description
Effect on Endometrial Thickening and Interaepitelial Maturation Index in Menopause Women
Timepoint
Three Months after the Intervention
Method of measurement
Vaginal Sonography and Pap smear
Intervention groups
1
Description
Taking 100 mg sildenafil tablets 1 hour before each vaginal intercourse for 3 months
Category
Treatment - Drugs
2
Description
Taking sildenafil tablets 1 hour before sexual intercourse for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology office
Full name of responsible person
Dr Zohre Shahverdi
Street address
No. 390, St. Eight, North Mofat, Shahid Beheshti Street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tarbiyat Modares Univercity
Full name of responsible person
Dr. Saeideh Ziaei
Street address
Tarbiyat Modares Univercity, Jalal Al Ahmad, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tarbiyat Modares Univercity