Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism (mprmih)

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.

Study Overview

• Status: Unknown
• Conditions: Hyperandrogenism; Menstrual Irregularities
• Intervention / Treatment: Drug: TAB METFORMIN; Drug: TAB PIOGLITAZONE

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jahan A Ainuddin; Phone Number: 03012530961; Email: jahanaraainuddin@yahoo.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75270
      • Recruiting
      • Dow University Hospital OJHA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metformin; TAB METFORMIN 500mg TDS	Drug: TAB METFORMIN; INSULIN SENSITIZING AGENTS
Experimental: pioglitazone; TAB PIOGLITAZONE 30 mg OD	Drug: TAB PIOGLITAZONE; INSULIN SENSITIZING AGENT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Study Director: Bader F Zuberi, FCPS, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Anticipated): December 17, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Metformin; PCO
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Gonadal Disorders; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Congenital Abnormalities; Hyperandrogenism; Menstruation Disturbances; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Pioglitazone
• Other Study ID Numbers: DowUHS3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No