Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Phase 1

• Conditions: Menstrual Irregularities; Hyperandrogenism
• Interventions: Drug: TAB METFORMIN; Drug: TAB PIOGLITAZONE

• Registration Number: NCT03757923
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.

Detailed Description

This study will be a prospective, randomized, open label, multicentre study. It will be carried out in outpatients department of Obstetrics and gynecology, at the Dow university of Hospital and mamji hospital Karachi.

The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or hyperprolactinemia.

Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute to greater concentration of free androgens in blood, cut off of insulin level for insulin resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing agents has been recently proposed as a useful treatment option in women with pcos, which by reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.

Study Timeline

• Study Start: 2018-06-18
• Study First Submitted: 2018-07-30
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-29
• Last Update Posted: 2018-11-29
• Primary Completion: 2018-12-17
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

1. women of age 18-40 with primary or secondary infertility.
2. Polycystic ovarian syndrome daignosed using rotterdam criteria.
3. Not taken any medication before for PCOS.

Exclusion Criteria

1. Women having type 1 or type 2 diabetes mellitus.
2. Abnormal kidney or liver function.
3. Hypertension or heart disease.
4. Gonadotrophin induction or ovarian drilling before will not be included in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin	TAB METFORMIN	TAB METFORMIN 500mg TDS
pioglitazone	TAB PIOGLITAZONE	TAB PIOGLITAZONE 30 mg OD

Primary Outcome Measures

Name	Time	Method
HIRSUTISM	3 months	Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
POLYCYSTIC OVARIES	3 months	assessment on ultrasound (qualitative-present/not present)
MENSTRUAL IRREGULARITIES	3 months	assessment on history(qualitative-present/not present)
BMI	3 months	weight and height will be combined to report BMI in kg/m2

Secondary Outcome Measures

Name	Time	Method
FREE TESTOSTERONE	3 months	unit of measure :nmol/l
FREE ANDROGEN INDEX	3 months	numerical
SERUM FASTING INSULIN	3 months	unit of measure: uIU/ml
FASTING BLOOD SUGAR	3 months	unit of measure:mg/dl

Trial Locations

Locations (1)

Dow University Hospital OJHA; 🇵🇰 Karachi, Sindh, Pakistan