Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Hyperandrogenism Clinical Trial

— mprmih  

Official title:

Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03757923
• Other study ID #: DowUHS3
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 18, 2018
• Est. completion date: January 2019

Study information

• Verified date: November 2018
• Source: Dow University of Health Sciences
• Contact: Jahan A Ainuddin
• Phone: 03012530961
• Email: jahanaraainuddin[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2019
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperandrogenism
• Menstrual Irregularities

Intervention

Drug:
• TAB METFORMIN
INSULIN SENSITIZING AGENTS
• TAB PIOGLITAZONE
INSULIN SENSITIZING AGENT

Locations

Country	Name	City	State
Pakistan	Dow University Hospital OJHA	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIRSUTISM	Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)	3 months
Primary	POLYCYSTIC OVARIES	assessment on ultrasound (qualitative-present/not present)	3 months
Primary	MENSTRUAL IRREGULARITIES	assessment on history(qualitative-present/not present)	3 months
Primary	BMI	weight and height will be combined to report BMI in kg/m2	3 months
Secondary	SERUM FASTING INSULIN	unit of measure: uIU/ml	3 months
Secondary	FASTING BLOOD SUGAR	unit of measure:mg/dl	3 months
Secondary	FREE TESTOSTERONE	unit of measure :nmol/l	3 months
Secondary	FREE ANDROGEN INDEX	numerical	3 months