NCT01003483

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

October 27, 2009

Last Update Submit

March 25, 2021

Conditions

Obesity

Keywords

metforminorlistatpcosobese

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    3 months

Secondary Outcomes (1)

  • Ovulatory

    3 months

Study Arms (2)

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

orlistatDRUG

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

Also known as: Xenical
MetforminOrlistat

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\>= 30
  • PCOS

You may not qualify if:

  • Drug use during last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research and Clinical Center for Infertility

Yazd, 8916877391, Iran

Location

MeSH Terms

Conditions

ObesityPolycystic Ovary Syndrome

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • Abbas Aflatoonian, Professor

    Research and Clinical center for Infertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

November 1, 2009

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

IR(1)