Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

NCT03757923 | Unknown Phase 1

• 1 other identifier: DowUHS3
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Irregularities; Hyperandrogenism

Keywords

PCO; Metformin

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• SERUM FASTING INSULIN

  3 months

• FASTING BLOOD SUGAR

  3 months

• FREE TESTOSTERONE

  3 months

• FREE ANDROGEN INDEX

  3 months

Study Arms (2)

metformin

EXPERIMENTAL

TAB METFORMIN 500mg TDS

Drug: TAB METFORMIN

pioglitazone

EXPERIMENTAL

TAB PIOGLITAZONE 30 mg OD

Drug: TAB PIOGLITAZONE

Interventions

TAB METFORMIN DRUG

INSULIN SENSITIZING AGENTS

metformin

TAB PIOGLITAZONE DRUG

INSULIN SENSITIZING AGENT

pioglitazone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University Hospital OJHA

Karachi, Sindh, 75270, Pakistan

RECRUITING

MeSH Terms

Conditions

Menstruation Disturbances; Hyperandrogenism

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bader F Zuberi, FCPS

  Dow University of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Jahan A Ainuddin

CONTACT

03012530961; jahanaraainuddin@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized controlled trail

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: November 29, 2018
• Study Start: June 18, 2018
• Primary Completion: December 17, 2018
• Study Completion: January 1, 2019
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)