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

Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01003483

Enrollment

Registered

2009-10-28

Start date

2008-12-01

Completion date

2009-11-30

Last updated

2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

metformin, orlistat, pcos, obese

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.

Interventions

DRUGorlistat

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI\>= 30 * PCOS

Exclusion criteria

* Drug use during last three months

Design outcomes

Primary

Measure	Time frame
Body Mass Index (BMI)	3 months

Secondary

Measure	Time frame
Ovulatory	3 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026