PCOS, Insulin ResistancePhase 4NCT02766803
Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
A Phase 4 study testing Simvastatin and micronized trans-resveratrol in people with PCOS, Insulin Resistance, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS, Insulin Resistance
- What is being tested?
- Simvastatin and micronized trans-resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- May 2016to Jun 2018
- Phase
- Phase 4
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOs
- insulin resistance
- normal prolactin, TSH, 17 OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
Who cannot join
- use of oral contraceptives and/or other steroid hormones 3 months prior to the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan, 60-184
Beata Banaszewska, Md Ph D, +48618419412, bbeata48@gmail.com
Robert Z Spaczynski, Md PhD Prof, +48618419412, rspaczynski@yahoo.com
About this study
Official title: Prospective, Randomized, Double - Blind Placebo Controlled Trial of Simvastatin and Resveratrol Therapy on Clinical, Endocrinological, Biochemical and Endothelial Dysfunction Parameters in Women With Polycystic Ovary Syndrome.
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production.
This study is designed to evaluate the endocrine and metabolic effects of simvastatin and resveratrol on PCOS.
Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering 20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after 3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and the fasting insulin level.
- Conditions
- PCOS, Insulin Resistance
- Being tested
- Simvastatin and micronized trans-resveratrol
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin and micronized trans-resveratrolDrug
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin + resveratrol | Active comparator | simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily Receives: Drug: Simvastatin and micronized trans-resveratrol |
| simvastatin+ placebo | Placebo comparator | simvastatin 20 mg daily Placebo Receives: Drug: Simvastatin and micronized trans-resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
testosterone serum concentration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
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 PCOS, Insulin ResistanceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Beata Banaszewska, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766803
- Sponsor's protocol ID
- PoznanUMS 3
- Status last verified
- Sep 2016
- First submitted
- 9 May 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.
PubMed 37462232
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double - Blind Placebo Controlled Trial of Simvastatin and Resveratrol Therapy on Clinical, Endocrinological, Biochemical and Endothelial Dysfunction Parameters in Women With Polycystic Ovary Syndrome.
- ClinicalTrials.gov ID
- NCT02766803
- Acronym / sponsor ID
- PoznanUMS 3
- Conditions
- PCOS, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- May 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 10 May 2016 (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.
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production.
This study is designed to evaluate the endocrine and metabolic effects of simvastatin and resveratrol on PCOS.
Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering 20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after 3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and the fasting insulin level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin + resveratrol | Active comparator | Drug: Simvastatin and micronized trans-resveratrolsimvastatin 20 mg daily micronized trans-resveratrol 500 mg daily |
| simvastatin+ placebo | Placebo comparator | Drug: Simvastatin and micronized trans-resveratrolsimvastatin 20 mg daily Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PCOs
- insulin resistance
- normal prolactin, TSH, 17 OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
Key exclusion criteria (1 listed)
- use of oral contraceptives and/or other steroid hormones 3 months prior to the study
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 |
|---|---|---|
| Simvastatin and micronized trans-resveratrol | Drug | Simvastatin + resveratrol, simvastatin+ placebo |
Primary outcome
testosterone serum concentration
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Derived from this study: PubMed 37462232Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.
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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.
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin and micronized trans-resveratrol in people with PCOS, Insulin Resistance, run by Poznan University of Medical Sciences at 1 site in Poland.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Sep 2016. 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 Poland. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
testosterone serum concentration (time frame: 2 years). 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 NCT02766803, 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 8 Sep 2016.