Because of the different ideas about epilepsy progesterone therapy this prospective double blind randomized clinical trial study conducted to investigate the efficacy of Progesterone as adjunctive therapy in intractable catamenial epilepsy. Subjects were 38 women between 18-40 years of age with intractable catamenial epilepsy who had clinically and electrographically documented refractory CPS, SGS, PGS. They were taking full dose antiepileptic drugs. They were divided into 2 groups by Random Allocation software. First group was taking antiepileptic drugs (AEDs) plus placebo and the second used progesterone (240 mg progesterone tablet (Majestrol) twice a day) additionally. Quality Indexes were done by Independent Sample t-Test and Fisher exact Test or Chi-Square applied for relative frequency comparison in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202128660N1
Registration date:2012-02-22, 1390/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-22, 1390/12/03
Registrant information
Name
Maedeh Mirmohamadsadeghi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
m-mirmohamadsadeghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-06-01, 1389/03/11
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of adjunctive Progesterone therapy effectiveness in intractable catamenial epilepsy
Public title
Progesterone therapy effectiveness in treatment of intractable catamenial epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- The women between 18 and 45 years of age who had clinically and electrographically documented refractory CPS or SGMS of temporal lobe origin; 2- All the women with demonstrated catamenial pattern of seizure exacerbation premenstrually between days 25 and 2 or during the entire luteal phase of the menstrual cycle between days 2 and 10; 3- The women with seizure exacerbation during the entire luteal phase with inadequate luteal phase cycles as documented by low serum progesterone levels less than 5 ng/ml during the mid-luteal phase; 5- The women who had premenstrual exacerbations with normal mid-luteal phase progesterone levels; 6- No pregnant and not lactating women who had no amenorrhea or had taken no major tranquilizers, antidepressant medications or OCP during 3 month prior to participate. Exclusion criteria: 1- Immigration; 2- Inaccessibility; 3- Giving up the participation; 4- Sever progesterone complications.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
389291
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.2
ICD-10 code description
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Primary outcomes
1
Description
Seizure frequency
Timepoint
3 months
Method of measurement
questionnaire
Secondary outcomes
1
Description
Seizure frequencies per month
Timepoint
1 month
Method of measurement
questionnaire
Intervention groups
1
Description
antiepileptic drugs + placebo
Category
Placebo
2
Description
antiepileptic drugs, intervention with 240 mg of progestron (Mejestrol) tablets twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
private office
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department, Medical school, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Taleb Azarm
Street address
Medical school, Isfahan University of Medical Sciences, Hezar jarib
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department, Medical school, Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Position
Associated professor of Neurology
Other areas of specialty/work
Street address
Alzahra Hospital, Sofe street
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
najafi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maedeh Mirmahamadsadeghi
Position
resident of Neurology
Other areas of specialty/work
Street address
Alzahra hospital, Sofe street
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
m_mirmohamadsadeghi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maedeh Mirmohamadsadeghi
Position
Resident Neurology
Other areas of specialty/work
Street address
Alzahra Hospital, Sofe street
City
Isfahan
Postal code
Phone
Fax
Email
m_mirmohamadsadeghi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)