AnovulationNCT00292799
An RCT of Metformin Vs Orlistat in Obese Anovulatory Women
A study testing Orlistat Vs Metformin in people with Anovulation and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to investigate the role of the weight reduction agent, Orlistat compared to the Metformin for the management of women who are obese and do not ovulate or have difficulty conceiving. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anovulation, Obesity
- What is being tested?
- Orlistat Vs Metformin
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Feb 2008
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 1. In the childbearing period 2. Obese with a body mass index of 30 or more. 3. Are anovulatory as shown by day 21-serum progesterone. 4. Polycystic ovarian syndrome will be diagnosed according if at least two of the following three features are present, after exclusion of other aetiologies (Azziz, 2004): (i) Oligo- or anovulation, (ii) Clinical and/or biochemical hyperandrogenism (iii) Polycystic ovaries.
Who cannot join
- BMI of less than 30
- Patients not requesting treatment for their symptoms
- Patients with contraindications for any of the medications: renal or hepatic impairment, malabsorption syndrome, cholestasis
- Diabetic patients
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Trust, Jessop Wing
Sheffield, S10 2SF
About this study
Official title: A Randomised Controlled Clinical Trial of Metformin Versus Orlistat for the Management of Obese Anovulatory Women.
This study aims to investigate the role of the weight reduction agent, Orlistat compared to the Metformin for the management of women who are obese and do not ovulate or have difficulty conceiving. Patients will receive either one of these medications and will be monitored at regular intervals with hormone blood tests and ultrasound scans in order to study the effect of the medications on the reproductive functions. Patients will receive the medications for three months and the study will end if the patient becomes pregnant. The study also aims to investigate the dose of metformin that should be used as there is no consensus to date regarding the optimum dosage for this drug
Read the detailed description
We aim to recruit 40 patients suffering from anovulatory obesity with a BMI of 30 or more. Patients will be included from all ethnic groups.
Patients will have a baseline history, clinical examination, hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including Doppler blood flow study (ovarian stromal velocity, PI, RI, SD ratio and power Doppler) Participants will then be randomised to receive either metformin or orlistat. Patients receiving orlistat will receive the standard dose of the drug as recommended in the BNF. Metformin will be given in an incremental dose starting at 1000mg per day and increased at 4 weekly intervals to 2000mg/d, depending on the occurrence of any gastrointestinal intolerance. The endocrinological and ultrasound investigations will be repeated at 4 weekly intervals. Both groups will be given a standard exercise and diet program in conjunction with medical treatment.
The clinical endpoint will be the achievement of conception, a Body Mass Index of less than 30, or completion of a 3-month course of treatment.
Study design:
A randomised controlled open label clinical trial. Participants be randomised using a computer generated randomisation program available at the pharmacy of the Jessop Wing, into either one of two arms: metformin or orlistat. The randomisation will be stratified in order to achieve a homogenous distribution of PCOS and non-PCOS patients in both arms of the study.
- Conditions
- Anovulation, Obesity
- Being tested
- Orlistat Vs Metformin
- Keywords
- Polycystic ovary syndrome, Obesity, metformin, orlistat
- Medical subject headings
- Anovulation, Obesity, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlistat Vs MetforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measures:
1- The occurrence of ovulation as measured by day-21 serum progesterone ( equal to or more than 30mmol/L).
2- Number of patients who have lost at least 5% of body weight at the end of the study.
3- Improvement/deterioration of clinical symptoms: hyper androgenic features, obesity and menstrual disturbances
4- Change in the ovarian Doppler indices.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnovulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Professor William L Ledger, D.Phil,FRCOG, Study chair, Sheffield UniversityDr Mostafa Metwally, Study director, Sheffield UniversityProfessor TC Li, Study chair, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292799
- Sponsor's protocol ID
- STH14007
- Status last verified
- Sep 2021
- First submitted
- 15 Feb 2006
- Last updated
- 27 Sep 2021
- Results posted
- No
Publications
Metwally M, Amer S, Li TC, Ledger WL. An RCT of metformin versus orlistat for the management of obese anovulatory women. Hum Reprod. 2009 Apr;24(4):966-75. doi: 10.1093/humrep/den454. Epub 2008 Dec 18.
PubMed 19095663
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Clinical Trial of Metformin Versus Orlistat for the Management of Obese Anovulatory Women.
- ClinicalTrials.gov ID
- NCT00292799
- Acronym / sponsor ID
- STH14007
- Conditions
- Anovulation, Obesity
- Keywords
- Polycystic ovary syndrome, Obesity, metformin, orlistat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Feb 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Feb 2006 (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.
This study aims to investigate the role of the weight reduction agent, Orlistat compared to the Metformin for the management of women who are obese and do not ovulate or have difficulty conceiving. Patients will receive either one of these medications and will be monitored at regular intervals with hormone blood tests and ultrasound scans in order to study the effect of the medications on the reproductive functions. Patients will receive the medications for three months and the study will end if the patient becomes pregnant. The study also aims to investigate the dose of metformin that should be used as there is no consensus to date regarding the optimum dosage for this drug
Detailed description
We aim to recruit 40 patients suffering from anovulatory obesity with a BMI of 30 or more. Patients will be included from all ethnic groups.
Patients will have a baseline history, clinical examination, hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including Doppler blood flow study (ovarian stromal velocity, PI, RI, SD ratio and power Doppler) Participants will then be randomised to receive either metformin or orlistat. Patients receiving orlistat will receive the standard dose of the drug as recommended in the BNF. Metformin will be given in an incremental dose starting at 1000mg per day and increased at 4 weekly intervals to 2000mg/d, depending on the occurrence of any gastrointestinal intolerance. The endocrinological and ultrasound investigations will be repeated at 4 weekly intervals. Both groups will be given a standard exercise and diet program in conjunction with medical treatment.
The clinical endpoint will be the achievement of conception, a Body Mass Index of less than 30, or completion of a 3-month course of treatment.
Study design:
A randomised controlled open label clinical trial. Participants be randomised using a computer generated randomisation program available at the pharmacy of the Jessop Wing, into either one of two arms: metformin or orlistat. The randomisation will be stratified in order to achieve a homogenous distribution of PCOS and non-PCOS patients in both arms of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. In the childbearing period 2. Obese with a body mass index of 30 or more. 3. Are anovulatory as shown by day 21-serum progesterone. 4. Polycystic ovarian syndrome will be diagnosed according if at least two of the following three features are present, after exclusion of other aetiologies (Azziz, 2004): (i) Oligo- or anovulation, (ii) Clinical and/or biochemical hyperandrogenism (iii) Polycystic ovaries.
Key exclusion criteria (6 listed)
- BMI of less than 30
- Patients not requesting treatment for their symptoms
- Patients with contraindications for any of the medications: renal or hepatic impairment, malabsorption syndrome, cholestasis
- Diabetic patients
- Pregnancy
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 |
|---|---|---|
| Orlistat Vs Metformin | Drug | – |
Primary outcome
Outcome measures:
1- The occurrence of ovulation as measured by day-21 serum progesterone ( equal to or more than 30mmol/L).
2- Number of patients who have lost at least 5% of body weight at the end of the study.
3- Improvement/deterioration of clinical symptoms: hyper androgenic features, obesity and menstrual disturbances
4- Change in the ovarian Doppler indices.
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 27 Sep 2021.
- Derived from this study: PubMed 19095663Metwally M, Amer S, Li TC, Ledger WL. An RCT of metformin versus orlistat for the management of obese anovulatory women. Hum Reprod. 2009 Apr;24(4):966-75. doi: 10.1093/humrep/den454. Epub 2008 Dec 18.
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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.
Professor William L Ledger, D.Phil,FRCOG study chair
Sheffield University
Dr Mostafa Metwally study director
Sheffield University
Professor TC Li study chair
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orlistat Vs Metformin in people with Anovulation and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 6 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 27 Sep 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 United Kingdom. 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.
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?
Outcome measures:. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292799, which also lists 1 linked publication.
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 27 Sep 2021.