Comparison of Metformin and Pioglitazone in Regulating Me... | NCT03757923

Studies
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

NCT03757923

Sponsor

Dow University of Health Sciences

Status

Unknown status

Last Update Posted

Nov 29, 2018Actual

Enrollment

110Estimated

Phase

Phase 1Phase 2

Conditions

Menstrual Irregularities
Hyperandrogenism

Interventions

TAB METFORMIN
TAB PIOGLITAZONE

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2018Actual

Primary Completion Date

Dec 17, 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Nov 28, 2018

First Posted Date

Nov 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2018

Last Update Posted Date

Nov 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jahan Ara Ainuddin, Professor, Dow University of Health SciencesPrincipal Investigator

Lead Sponsor

Dow University of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metformin	Experimental	TAB METFORMIN 500mg TDS	Drug: TAB METFORMIN
pioglitazone	Experimental	TAB PIOGLITAZONE 30 mg OD	Drug: TAB PIOGLITAZONE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAB METFORMIN	Drug	INSULIN SENSITIZING AGENTS	metformin
TAB PIOGLITAZONE

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
SERUM FASTING INSULIN	unit of measure: uIU/ml	3 months
FASTING BLOOD SUGAR	unit of measure:mg/dl	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jahan A Ainuddin	Contact	03012530961		jahanaraainuddin@yahoo.com

Overall Officials

Name	Affiliation	Role
Bader F Zuberi, FCPS	Dow University of Health Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dow University Hospital OJHA	Recruiting	Karachi	Sindh	75270	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008599	Menstruation Disturbances
D017588	Hyperandrogenism

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D058489	46, XX Disorders of Sex Development
D012734	Disorders of Sex Development

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
D000077205	Pioglitazone

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D045162

Browse Leaves

Not provided

Browse Branches

Not provided