Adults 20 to 40, female only, with Polycystic Ovarian Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cytokines and Chemokines MeasurementsPrimary· Baseline and after 3 Months
IL-6 and IL-8 levels by ELISA method using commercially available kits.
IL-6 levels at baseline
Group
Value
95% CI
Metformin
14.60
12.05 – 17.69
Metformin, Pioglitazone
14.12
11.58 – 17.23
IL-6 levels after 3 months of treatment
Group
Value
95% CI
Metformin
12.65
10.61 – 15.08
Metformin, Pioglitazone
11.12
10.02 – 12.33
IL-8 Llevels at baseline
Group
Value
95% CI
Metformin
61.92
52.95 – 72.41
Metformin, Pioglitazone
41.86
38.24 – 45.83
IL-8 Llevels after treatment
Group
Value
95% CI
Metformin
32.70
22.99 – 46.50
Metformin, Pioglitazone
22.00
16.76 – 28.88
Hormonal ProfilesSecondary· Baseine and after 3 Months
Serum level of LH was measure at baseline and after 3 months of treatment
LH level at baseline
Group
Value
95% CI
Metformin
5.79
4.95 – 6.77
Metformin, Pioglitazone
6.625
5.52 – 7.94
LH level after treatment
Group
Value
95% CI
Metformin
4.92
4.33 – 5.59
Metformin, Pioglitazone
5.16
4.50 – 5.91
Insulin ResistanceSecondary· Baseline and after 3 months
Insulin resistance was measure by calculating HOMA-IR from the data of insulin and sugar levels.
HOMA-IR at baseline
Group
Value
95% CI
Metformin
7.19
± 3.00
Metformin, Pioglitazone
6.22
± 2.65
HOMA-IR after treatment
Group
Value
95% CI
Metformin
3.97
± 2.03
Metformin, Pioglitazone
3.84
± 2.13
Sponsor's own description
Objective:
1. To investigate the changes in the levels of interleukin-6 and interleukin-8 after 3 months treatment with metformin alone and combination of metformin and pioglitazone in patients with polycystic ovarian syndrome (PCOS).
2. To evaluate insulin resistance in all the groups at baseline and after 3 months of treatment.
Design: Two-Arm Randomized Clinical trial.
Setting: Out-Patient Department (OPD) of Mardan Medical Complex, Khyber Medical University.
Patient(s): One hundred and two patients with PCOS.
Intervention(s): 51 women will receive metformin according to the body weight with maximum dose of 1000 mg (BD) daily. Remaining 51 will receive metformin and pioglitazone combination according to the body weight with maximum dose of 1000 mg and 30 mg (BD) daily.
Main outcomes measure(s): Serum concentrations of fasting blood glucose, insulin, homeostatic model assessment for insulin resistance (HOMA-IR), follicle stimulating hormone (FSH), luteinizing hormone (LH), interleukin-6 (IL-6) and i-nterleukin-8 (IL-8).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Khyber Medical University Peshawar
Last refreshed: 2 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03117517.