Metformin Versus Orlistat in Obese Polycystic Ovary Syndr... | NCT01003483

Studies
Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients

NCT01003483

Sponsor

Yazd Research & Clinical Center for Infertility

Status

Completed

Last Update Posted

Apr 1, 2021Actual

Enrollment

80Actual

Phase

Phase 2

Conditions

Obesity

Interventions

orlistat

Countries

Iran

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2008Actual

Primary Completion Date

Aug 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Oct 27, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

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

Mar 25, 2021

Last Update Posted Date

Apr 1, 2021Actual

Name	Class
Yazd Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women.

Detailed Description

In a randomized clinical trial study, 80 obese women with BMI≥30, oligomenorrhae, hirsutism and presence of > 12 ovarian follicles (2-10mm diameter), were evaluated. In metformin group , metformin was administered for patients 1500 mg daily for three months. In orlistate group, patients used orlistat tablets (120 mg, 3 times a day) for three months. BMI, serum LH and FSH levels, serum triglyceride and cholesterol levels and also patients' ovulation was compared before and after treatment.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orlistat	Experimental	The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.	Drug: orlistat
Metformin	Experimental	The dose of metformin was increased step - wise, from 500 mg once daily for the first week to 500 mg twice daily for the next week, and to 500 mg three times daily for the remaining study period .	Drug: orlistat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
orlistat	Drug	Tablet,120mg,three times a day,three months	Metformin Orlistat

Measure	Description	Time Frame
Body Mass Index (BMI)		3 months

Measure	Description	Time Frame
Ovulatory		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI>= 30
PCOS

Exclusion Criteria:

Drug use during last three months

Accepts Healthy Volunteers

Yes

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

Not provided

Overall Officials

Name	Affiliation	Role
Abbas Aflatoonian, Professor	Research and Clinical center for Infertility	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research and Clinical Center for Infertility		Yazd		8916877391	Iran

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077403	Orlistat

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided