Polycystic Ovary SyndromeNCT01526616
Spironolactone Plus Metformin in Polycystic Ovary Syndrome
A study testing Metformin and Metformin plus Spironolactone in people with Polycystic Ovary Syndrome, run by University Magna Graecia.
Trial summary
The investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin and Metformin plus Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jul 2011
- 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 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Overweight/obese patients with PCOS
Who cannot join
- Other causes of hyperandrogenism and
- Use of drugs including:
- oral contraceptive
- anti-hypertensive agents
- anti-diabetic drugs
- agents for weight loss
About this study
Official title: Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
The investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients.
Read the detailed description
In the present prospective, randomized study, we evaluated the efficacy of a combined therapy with metformin and low-dose spironolactone as compared to metformin alone on the clinical and endocrine-metabolic alterations of PCOS patients.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Metformin plus Spironolactone
- Keywords
- PCOS, metformin, spironolactone, metabolic syndrome, hyperandrogenism
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 850 mg twice a day for six months
Metformin plus SpironolactoneDrug
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | 850 mg/day twice a day Receives: Drug: Metformin |
| Metformin plus spironolactone | Active comparator | Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day Receives: Drug: Metformin plus Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
We evaluated metabolic parameters across anthropometric parameters: height, weight, waist circumference, BMI, glycemia, lipid profile, blood count, coagulation parameters, hepatic and renal function indexes, OGTT and HOMA-IR. The diagnosis of MetS was established according to the ATPIII criteria
Measured: six months
Secondary outcomes (1)
Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome
We evaluated hyperandrogenism across Hirsutism Score, measuring total testosterone, SHBG, Δ4androstenedione, DHEA-S and FAI. All patients underwent ovarian ultrasound examination.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionJul 2011
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 Polycystic Ovary SyndromeStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Antonino Belfiore, University Magna Graecia
- Investigators
- A. Mazza B. Fruci A. Belfiore, Doctors, Principal investigator, Endocrinology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526616
- Sponsor's protocol ID
- 2010.31
- Status last verified
- Feb 2012
- First submitted
- 27 Jan 2012
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mazza A, Fruci B, Guzzi P, D'Orrico B, Malaguarnera R, Veltri P, Fava A, Belfiore A. In PCOS patients the addition of low-dose spironolactone induces a more marked reduction of clinical and biochemical hyperandrogenism than metformin alone. Nutr Metab Cardiovasc Dis. 2014 Feb;24(2):132-9. doi: 10.1016/j.numecd.2013.04.016. Epub 2013 Jul 8.
PubMed 23845740
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
- ClinicalTrials.gov ID
- NCT01526616
- Acronym / sponsor ID
- 2010.31
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, metformin, spironolactone, metabolic syndrome, hyperandrogenism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Feb 2012 (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 investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients.
Detailed description
In the present prospective, randomized study, we evaluated the efficacy of a combined therapy with metformin and low-dose spironolactone as compared to metformin alone on the clinical and endocrine-metabolic alterations of PCOS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin850 mg/day twice a day |
| Metformin plus spironolactone | Active comparator | Drug: Metformin plus SpironolactoneMetformin 850 mg twice a day for six months plus Spironolactone 25 mg day |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Overweight/obese patients with PCOS
Key exclusion criteria (6 listed)
- Other causes of hyperandrogenism and
- Use of drugs including:
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 |
|---|---|---|
| MetforminMetformin 850 mg twice a day for six months | Drug | Metformin |
| Metformin plus SpironolactoneMetformin 850 mg twice a day for six months plus Spironolactone 25 mg day | Drug | Metformin plus spironolactone |
Primary outcome
Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
Time frame: six months
We evaluated metabolic parameters across anthropometric parameters: height, weight, waist circumference, BMI, glycemia, lipid profile, blood count, coagulation parameters, hepatic and renal function indexes, OGTT and HOMA-IR. The diagnosis of MetS was established according to the ATPIII criteria
1 secondary outcome
Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome
Time frame: six 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 6 Feb 2012.
- Derived from this study: PubMed 23845740Mazza A, Fruci B, Guzzi P, D'Orrico B, Malaguarnera R, Veltri P, Fava A, Belfiore A. In PCOS patients the addition of low-dose spironolactone induces a more marked reduction of clinical and biochemical hyperandrogenism than metformin alone. Nutr Metab Cardiovasc Dis. 2014 Feb;24(2):132-9. doi: 10.1016/j.numecd.2013.04.016. Epub 2013 Jul 8.
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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.
A. Mazza B. Fruci A. Belfiore, Doctors principal investigator
Endocrinology Unit
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Metformin plus Spironolactone in people with Polycystic Ovary Syndrome, run by University Magna Graecia.
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 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study (time frame: six months). 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 NCT01526616, 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 6 Feb 2012.