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

The Efficacy of pioglitazone in comparison with OCP on symptoms and stage of endometriosis in a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201102195867N1
Enrollment
60
Registered
2011-04-02
Start date
2010-05-23
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

Endometriosis.

Interventions

Intervention 1: Intervention group: 30 mg pioglitazone daily for 6 months. Intervention 2: Control group: OCP (LD) one pill daily for 6 months.
Treatment - Drugs
Intervention group: 30 mg pioglitazone daily for 6 months
Control group: OCP (LD) one pill daily for 6 months

Sponsors

Tehran University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHaydeh Samiee

Tehran University of Medical Sciences

hsamiee@sina.tums.ac.ir+98 21 7788 3288

Outcome results

None listed

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