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Progesterone therapy effectiveness in treatment of intractable catamenial epilepsy

The study of adjunctive Progesterone therapy effectiveness in intractable catamenial epilepsy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201202128660N1
Enrollment
38
Registered
2012-02-22
Start date
2010-06-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy. Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures

Interventions

Intervention 1: antiepileptic drugs + placebo. Intervention 2: antiepileptic drugs, intervention with 240 mg of progestron (Mejestrol) tablets twice a day.
Placebo
Treatment - Drugs
antiepileptic drugs + placebo
antiepileptic drugs, intervention with 240 mg of progestron (Mejestrol) tablets twice a day

Sponsors

Research Department, Medical school, Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

MeasureTime frame
Seizure frequencies per month. Timepoint: 1 month. Method of measurement: questionnaire.

Primary

MeasureTime frame
Seizure frequency. Timepoint: 3 months. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Najafi

Isfahan University of Medical Sciences

najafi@med.mui.ac.ir+98 31 1625 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026