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

NCT ID: NCT01003483

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-01

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Orlistat

The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.

Group Type EXPERIMENTAL

orlistat

Intervention Type DRUG

Tablet,120mg,three times a day,three months

Metformin

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 .

Group Type EXPERIMENTAL

orlistat

Intervention Type DRUG

Tablet,120mg,three times a day,three months

Interventions

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orlistat

Tablet,120mg,three times a day,three months

Intervention Type DRUG

Other Intervention Names

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Xenical

Eligibility Criteria

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Inclusion Criteria

* BMI\>= 30
* PCOS

Exclusion Criteria

* Drug use during last three months
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yazd Medical University

OTHER

Sponsor Role collaborator

Yazd Research & Clinical Center for Infertility

OTHER

Sponsor Role lead

Responsible Party

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Nasim Tabibnejad

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abbas Aflatoonian, Professor

Role: PRINCIPAL_INVESTIGATOR

Research and Clinical center for Infertility

Locations

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Research and Clinical Center for Infertility

Yazd, , Iran

Site Status

Countries

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Iran

Other Identifiers

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616

Identifier Type: -

Identifier Source: org_study_id

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