Introduction and aims: Proper treatment of labia adhesion is important because of increasing risk of urinary tract infection in the presence of other risk factors. In addition, a serum level of estradiol in those patients is still controversial. This study investigated the relationship between serum estradiol levels and topical estrogen cream in labia adhesion. Methods and materials: This double-blind clinical trial was performed in Taleghani Haspital in Gorgan city at 2010. 3-08 months children with more than 25% adhesion Labia were treated with topical estrogen cream, in one week. Blood estradiol levels were measured before and after treatment and evaluated based on response to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121611560N1
Registration date:2013-01-31, 1391/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-31, 1391/11/12
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gorgan University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-04-01, 1391/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Relationship between serum estradiol levels and topical estrogen cream used in girls with labial adhesions
Public title
Relationship between serum estradiol levels and topical estrogen cream used in girls with labial adhesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age between 3 months and 8 years; no puberty ; labia adhesion >25%; no voluvagenitis. Exclusion Criteria : no use of Drug; no follow up; adverse drug reaction.
Age
To 9 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gorgan University of Medical Sciences
Street address
Imam Khomeni Sq
City
Gorgan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
15991012902
Health conditions studied
1
Description of health condition studied
Minor Labial Adhesion
ICD-10 code
N90.8
ICD-10 code description
Adhesions of vulva
Primary outcomes
1
Description
release of adhesion
Timepoint
7 days
Method of measurement
Clinical Examination
Secondary outcomes
1
Description
no urinery track infection
Timepoint
3 month
Method of measurement
clinical Examination; history
Intervention groups
1
Description
EQUIN conjugated estrogens USP, 0.625 mg/g, Spain, daily, seven days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Baranak Safaian
Street address
Pediatrics Ward, Taleghani Hospital, Imam khomeini St
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Shahryar Semnanei
Street address
Iamam Khomeni st.
City
Gorgn
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 and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Baranak Safaian
Position
Assisstan professor
Other areas of specialty/work
Street address
Imam Khomeni st.
City
Gorgan
Postal code
Phone
+98 21 5542 7642
Fax
Email
safaian_baranak@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Baranak Safaian
Position
Assisstan professor
Other areas of specialty/work
Street address
Imam Khomeni st.
City
Gorgan
Postal code
Phone
+98 21 5542 7642
Fax
Email
safaian_baranak@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Tayeb Ramim
Position
Assisstant Professor
Other areas of specialty/work
Street address
Imam Khomeini st.
City
Gorgan
Postal code
Phone
+98 215542642
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)