ObesityPhase 2NCT01003483
Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
A Phase 2 study testing orlistat in people with Obesity, run by Yazd Research & Clinical Center for Infertility at 1 site in Iran.
Trial summary
The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- orlistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 1 Dec 2008to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI>= 30
- PCOS
Who cannot join
- Drug use during last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women
The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women.
Read the 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.
- Conditions
- Obesity
- Being tested
- orlistat
- Keywords
- metformin, orlistat, pcos, obese
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orlistatDrug
Also called Xenical
Tablet,120mg,three times a day,three months
| Study group | Role | What they receive |
|---|---|---|
| Orlistat | Experimental | The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period. Receives: 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 . Receives: Drug: orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Measured: 3 months
Secondary outcomes (1)
Ovulatory
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study start1 Dec 2008
- Primary completionAug 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yazd Research & Clinical Center for Infertility
- Sponsor type
- University, hospital or other
- Collaborators
- Yazd Medical University
- Responsible party
- Principal investigator, Nasim Tabibnejad, Yazd Research & Clinical Center for Infertility
- Investigators
- Abbas Aflatoonian, Professor, Principal investigator, Research and Clinical center for Infertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003483
- Sponsor's protocol ID
- 616
- Status last verified
- Mar 2021
- First submitted
- 27 Oct 2009
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women
- ClinicalTrials.gov ID
- NCT01003483
- Acronym / sponsor ID
- 616
- Conditions
- Obesity
- Keywords
- metformin, orlistat, pcos, obese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yazd Research & Clinical Center for InfertilityUniversity, hospital or other
- Collaborators
- Yazd Medical University
- Study start
- 1 Dec 2008 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orlistat | Experimental | Drug: orlistatThe dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period. |
| Metformin | Experimental | Drug: orlistatThe 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 . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI>= 30
- PCOS
Key exclusion criteria (1 listed)
- Drug use during last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orlistatAlso: XenicalTablet,120mg,three times a day,three months | Drug | Metformin, Orlistat |
Primary outcome
Body Mass Index (BMI)
Time frame: 3 months
1 secondary outcome
Ovulatory
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas Aflatoonian, Professor principal investigator
Research and Clinical center for Infertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing orlistat in people with Obesity, run by Yazd Research & Clinical Center for Infertility at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.