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Evaluation of the effectiveness of Gabapentin vaginal gel on pain control in patients with Dyspareunia; A double-blind randomized clinical trial

Protocol summary

Study aim
Determining the effectiveness of Gabapentin vaginal gel on patients with Dyspareunia
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 60 patients, using dice and sealed envelopes for randomization.
Settings and conduct
Shahid Sadoughi Hospital, Women's Clinic, Yazd, patients who meet the inclusion criteria are placed in one of the two treatment groups with Gabapentin gel product (group A) or Basic Hydrogel (group B). Randomization is done based on the (RAND) function of Excel, and based on this, a table of random numbers is prepared, and the patients are placed in group A or B according to the rows of this table, and receive the product related to their group. All of the creams of one numbered form will be available to the attending physician and them. Patients will be evaluated for one month on days 0, 7, 14, 21 and 28
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 50 years, married, suffering from dyspareunia, not allergic to gabapentin and vaginal gel base ingredients, not taking vaginal painkillers or gabapentin within a week before the start of the study, Consent to participate in the study and complete the informed consent form. non-entry criteria: history of psychiatric diseases (psychosis), acute and chronic vaginal infection, female genital cancer, pregnancy, and breastfeeding.
Intervention groups
intervention group: Treatment with Gabapentin vaginal gel (gabapentin, carbomer, hydroxypropyl methylcellulose ) 5%, once a day, topical use (vaginally) for up to 4 weeks control group: Treatment with placebo vaginal gel (carbomer, hydroxypropyl methylcellulose), once a day, topical application (vaginally) for up to 4 weeks
Main outcome variables
NRS pain scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191106045356N13
Registration date: 2022-10-31, 1401/08/09
Registration timing: registered_while_recruiting

Last update: 2022-10-31, 1401/08/09
Update count: 0
Registration date
2022-10-31, 1401/08/09
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Gabapentin vaginal gel on pain control in patients with Dyspareunia; A double-blind randomized clinical trial
Public title
Evaluation of the effects of Gabapentin vaginal gel on Dyspareunia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
married Suffering from Dyspareunia Insensitivity to gabapentin and vaginal gel base ingredients Not taking vaginal painkillers or systemic gabapentin one week before the start of the study Consent to participate in the study and complete the informed consent form
Exclusion criteria:
History of psychiatric diseases Acute and chronic vaginal infection cancer of the female genital tract Pregnancy and breastfeeding
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization will be done based on the (RAND) function of Excel and based on this, a table of random numbers is prepared, and the patients are placed in groups A or B according to the rows of this table, and receive the product related to their group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be done in a double-blind manner. Patients and doctors (therapist and evaluator) will not know about the intervention. Worms are numbered by one of the researchers who does not intervene in the study process (treatment, evaluation and data analysis) with labels one and two, and only the same researcher knows about the numbering of worms. Then the numbered creams are delivered to the patients by the doctor.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
thics committee of ُ Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2022-06-26, 1401/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1401.073

Health conditions studied

1

Description of health condition studied
Dyspareunia
ICD-10 code
N94.1
ICD-10 code description
Dyspareunia

Primary outcomes

1

Description
NSR Pain Scale
Timepoint
Measurement of NRS scale at the beginning of the study and on days 7, 14, 21 and 28 days after the start of gabapentin gel consumption.
Method of measurement
NRS Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 patients with dyspareunia who were treated with 5% gabapentin vaginal gel (gabapentin, hydroxypropyl methylcellulose and carbomer), topical use (vaginal), daily for one to one month.
Category
Treatment - Drugs

2

Description
Control group: 30 patients with dyspareunia who were treated with placebo vaginal gel (hydroxypropyl methyl cellulose and carbomer) used topically (vaginally), once a day for a month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Leyla Zanbagh
Street address
Shahid Sadoughi Hospital, Ibn Sina Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4000
Email
mzabihi100@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mohsen Zabihi
Street address
Shahid Sadoughi University, Prof. Hessabi Ave, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4000
Email
mzabihi100@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
Mohsen Zabihi Professor of Pharmacology, Yazd University of Medical Sciences +98 913 153 6813 mzabihi100@gmail.com
What processes are involved for a request to access data/document
No specific details are considered
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