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Progesterone therapy effectiveness in treatment of intractable catamenial epilepsy

Phase 2
Conditions
Epilepsy.
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Registration Number
IRCT201202128660N1
Lead Sponsor
Research Department, Medical school, Isfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
38
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.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Seizure frequency. Timepoint: 3 months. Method of measurement: questionnaire.
Secondary Outcome Measures
NameTimeMethod
Seizure frequencies per month. Timepoint: 1 month. Method of measurement: questionnaire.
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