MedPath

The Efficacy of pioglitazone in comparison with OCP on symptoms and stage of endometriosis

Phase 2
Conditions
Endometriosis.
Registration Number
IRCT201102195867N1
Lead Sponsor
Tehran University Of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
60
Inclusion Criteria

Approved case of endometriosis with laparoscopy, patients in stage less than 4 according to rAFS criteria
Exclusion criteria: Pregnant and breastfeeding women, Intake of OCP in recent month, Diabetes, Cardiac Functional Class III and IV, Liver dysfunction, Cancer diseases, Pelvic pain with other causes, Abnormal WBC count, FBS/Insulin less than 4.5 , Patients older than 35 years old who smoke more than 15 cigarette per day, Co-existence of multiple cardiovascular risk factors including: (old age, cigarette smoker, diabetes, blood pressure more than 160/100 and vascular disease), Thromboembolic disease, Recent major surgery with prolonged immobilization, Past history or presence of ischemic heart or stroke, Cardiac valvular disease, Migrain with aura or without aura in patients above 35 years old, No severe adhesions, No other treatment interfering with endometriotic lesions, No GnRh or corticosteroid therapy in recent 3 months, No surgical intervention other than endometrioma evacuation in recent 12 months

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Endometriosis stage. Timepoint: At the beginning/after 6 months. Method of measurement: by ob-gyn specialist with rAFS criteria.;Endometriosis score. Timepoint: At the beginning/after 6 months. Method of measurement: by ob-gyn specialist with rAFS criteria.
Secondary Outcome Measures
NameTimeMethod
Subjective endometriosis symptoms. Timepoint: At the beginning/after 3 months and 6 months. Method of measurement: modified Biberoglu and Behrman symptom severity scale (BB).;Patients’ perception of sensory and affective dimension of pain. Timepoint: At the beginning/after 3 months and 6 months. Method of measurement: Short-Form McGill Pain Questionnaire.;Severity of pain. Timepoint: At the beginning/after 3 months and 6 months. Method of measurement: scale of 0 to 5.;Quality of life. Timepoint: At the beginning/after 3 months and 6 months. Method of measurement: SF12.;Anxiety/Depression. Timepoint: At the beginning/after 3 months and 6 months. Method of measurement: HADS questionnaire.
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