Early Phase 1 Completed N=106 Randomized Double-blind Treatment

Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome

Polycystic Ovarian Syndrome

Source: ClinicalTrials.gov NCT03117517 ↗

Enrolled (actual)

106

Serious AEs

—

Results posted

Mar 2020

Primary outcomePrimary: Cytokines and Chemokines Measurements — 14.60; 14.12; 12.65; 11.12 pg/ml

Summary

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Cytokines and Chemokines Measurements	14.60; 14.12; 12.65; 11.12; 61.92; 41.86	—
SECONDARY Hormonal Profiles	5.79; 6.625; 4.92; 5.16	—
SECONDARY Insulin Resistance	7.19; 6.22; 3.97; 3.84	—

Eligibility Criteria

Inclusion Criteria

Clinically diagnosed patients of PCOS.
Must Swallow the tablet(s).
Must give informed consent.

Exclusion Criteria

Women with cushing syndrome, hyperprolactinemia.
Late onset congenital adrenal hyperplasia, androgen-producing tumors, pregnancy.
Insulin dependent diabetes.
Thyroid disease.
Medications that alters the biochemical or hormonal profile.

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Data sourced from ClinicalTrials.gov (NCT03117517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.