Determining the effect of vaginal gel on the sexual function of women of reproductive age
Design
Randomized, superiority, parallel group trial with blinded outcome assessment. Randomization was done using Random Allocation Software.
Settings and conduct
The place of study is women's clinics covered by Mashhad University of Medical Sciences and midwifery consultation clinics. The study population is women of reproductive age. The research is triple blind. For blinding, two groups were used, including the intervention group that receives the vaginal gel and the control group that receives the placebo, the vaginal gel and placebo have the same appearance. Each research unit is randomly assigned to group A or B (blinding of the research unit and the researcher), and completes the FSFI and DASS-21 form. Then they are asked to use an applicator of 5% vaginal gel or placebo 15 minutes before sexual intercourse, for 4 weeks. At the end of the 4th week, the FSFI questionnaire is filled again. The analysis is done without the knowledge of the statistical consultant of the people in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
A married woman of reproductive age (18-40) years old;
Having a sexual function score based on the FSFI questionnaire is less than 28
Having sex at least once a week;
Exclusion criteria:
pregnancy and breastfeeding;
vaginal atrophy;
Allergy to herbal substances
Intervention groups
The intervention group includes 38 people who use an applicator of 5% vaginal gel 15 minutes before sexual intercourse for 4 weeks. The control group includes 38 people who use placebo in the same way.
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230723058892N1
Registration date:2023-08-30, 1402/06/08
Registration timing:registered_while_recruiting
Last update:2023-08-30, 1402/06/08
Update count:0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
bahareh khajehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 8387
Email address
khajehpourbahareh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of vaginal gel of myrtus communis on Sexual Function of married women during Reproductive Ages
Public title
The effects of myrtus communis on Sexual Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A married woman of reproductive age (18-40) years old
Having informed consent to participate in the research
Having a sexual function score based on the FSFI questionnaire is less than 28
Has a history of NVD
Having sex at least once a week
A resident of Mashhad or the suburbs
Having at least reading and writing literacy
Having a regular period cycle (26-32 days) and not having AUB
Having a depression score of less than 21, anxiety less than 15, and stress less than 26 in the DASS questionnaire
Exclusion criteria:
Allergy to herbal substances or herbs
pregnancy and breastfeeding
infertility
hormone therapy or use of sex hormones 2 months before the study
Specific mental illness in couples and specific medical illness affecting sexual function in women and husbands
vaginal atrophy
Pelvic radiation therapy or chemotherapy to treat cancer
oophorectomy
early menopause
uncontrolled diabetes
Treatment with drugs used to reduce estrogen levels in women with endometriosis
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
The necessary sample is selected in an easy and accessible way, and then the permutation block method is used to generate the sequence of random allocation of people to the studied groups. Random allocation sequence of people will be done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups. There are six blocks in this study. One of the blocks is randomly selected. If the first block is AABB, the first and second people will be assigned to group A, and the third and fourth people will be assigned to group B, and this process continues until all the samples will be assigned. The characteristic of this method is that the two study groups will have equal numbers
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is a triple-blind randomized clinical trial. That is, the researcher, the research unit and the statistical consultant do not know the type of drug given (vaginal gel or placebo).The gel is made with a completely identical appearance to the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Baharestan dormitory 2; Medical Sciences Campus; Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2023-07-22, 1402/04/31
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.057
Health conditions studied
1
Description of health condition studied
Sexual function and sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function score in the FSFI questionnaire
Timepoint
Measurement of sexual function at the beginning of the study (before the start of the intervention) and 4 weeks after using the vaginal gel
Method of measurement
Female Sexual Function Index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group includes 38 people who will use an applicator of 5% case leaf vaginal gel, 15 minutes before sexual intercourse for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group:This group included 38 people who used a placebo applicator 15 minutes before sexual intercourse for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Clinic of Ghaem Hospital
Full name of responsible person
Mohammad Moeini Nodeh
Street address
Qaem educational research and treatment center; Central Clinic; The beginning of Ahmedabad street; Dr. Shariati square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766_99199
Phone
+98 51 3840 0001
Fax
Email
MoeiniNM@mums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Reza Educational, Research and Treatment Center