Polycystic Ovary SyndromeEarly Phase 1AntiPCONCT02689843
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS
A Early Phase 1 study testing Cyproterone compound + Spironolactone, Metformin and Pioglitazone in people with Polycystic Ovary Syndrome, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)]… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Cyproterone compound + Spironolactone, Metformin and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2018to 30 Dec 2018
- Phase
- Early Phase 1
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-35 years
- Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):
- Oligomenorrhea or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries (by ultrasound)
Who cannot join
- Smoking
- Pregnancy
- Diabetes mellitus
- Renal failure (serum creatinine >1.5)
- Congenital adrenal hyperplasia
- Hyper or hypothyroidism
Show all 12Show fewer
- Sex hormone therapy or antiandrogen therapy during the last three months
- Unexplained serum alanin aminotransferase (ALT) elevation more than 2.5 times above normal range
- Any systemic or febrile illnesses
- Use of glucocorticoid or anti-inflammatory drugs during the last three months
- Androgen secreting tumor
- Malignancy
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
About this study
Official title: Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)
The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)] levels.
Read the detailed description
Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive age, making it one of the most common endocrine disorders in this population. PCOS is associated with a broad range of adverse sequel, including hypertension, dyslipidemia, insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized as a component of the metabolic syndrome. Management depends on symptoms or the source of androgen excess. Several treatment options are available, which allows for an individualized approach. Spironolactone is the safest potent available antiandrogen. It is effective in lowering the hirsutism score by approximately one third, although considerable individual variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase insulin sensitivity, but their mechanism of action differ.
Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be linked with insulin resistance.
The investigators want to measure serum complement, homocysteine and hs-CRP levels in patients with PCOS before and after three-month course of treatment with Cyproterone compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Cyproterone compound + Spironolactone, Metformin, Pioglitazone
- Keywords
- Inflammation, Complement system proteins, Homocysteine, C-Reactive Protein, Cyproterone, Ethinyl Estradiol, Androgen Antagonists, Metformin, Thiazolidinediones, Pioglitazone
- Medical subject headings
- Polycystic Ovary Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproterone compound + SpironolactoneDrug
Also called CC-S
Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily
MetforminDrug
Metformin 500mg three times daily
PioglitazoneDrug
Pioglitazone 30mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Cyproterone compound + Spironolactone | Active comparator | Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily Receives: Drug: Cyproterone compound + Spironolactone |
| Metformin | Active comparator | Metformin 1500 mg daily Receives: Drug: Metformin |
| Pioglitazone | Active comparator | Pioglitazone 30 mg daily Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum C3 level
Serum concentration of a component of complement cascade: C3
Measured: 3 months
Serum C4 level
Serum concentration of a component of complement cascade: C4
Measured: 3 months
Serum high-sensitive CRP (C-reactive protein)
Serum concentration of high-sensitive C-reactive protein (hs-CRP)
Measured: 3 months
Secondary outcomes (9)
Serum total Testosterone level
Serum concentration of total Testosterone
Measured: 3 months
Serum free Testosterone level
Serum concentration of free Testosterone
Measured: 3 months
Serum Dehydroepiandrosterone sulfate (DHEAS) level
Serum concentration of Dehydroepiandrosterone sulfate
Measured: 3 months
Serum follicle stimulating hormone (FSH) level
Serum concentration of follicle stimulating hormone
Measured: 3 months
Serum luteinizing hormone (LH) level
Serum concentration of luteinizing hormone
Measured: 3 months
Fasting Blood Sugar (FBS)
Fasting Blood Sugar
Measured: 3 months
Fasting Serum Insulin level
Serum concentration of insulin
Measured: 3 months
Serum homocysteine level
Serum concentration of homocysteine
Measured: 3 months
Number of patients with adverse events
Number of patients with adverse events
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 posted24 Feb 2016 (estimated)
- Study start1 Feb 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Mesbah Shams, MD, Principal investigator, Endocrine and Metabolism Research Center, Shiraz University of Medical SciencesGholamhossein R Omrani, MD, Study chair, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689843
- Sponsor's protocol ID
- CT-P-9145-4025
- Acronym
- AntiPCO
- Status last verified
- Nov 2019
- First submitted
- 19 Feb 2016
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT02689843
- Acronym / sponsor ID
- AntiPCO / CT-P-9145-4025
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Inflammation, Complement system proteins, Homocysteine, C-Reactive Protein, Cyproterone, Ethinyl Estradiol, Androgen Antagonists, Metformin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 24 Feb 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.
The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)] levels.
Detailed description
Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive age, making it one of the most common endocrine disorders in this population. PCOS is associated with a broad range of adverse sequel, including hypertension, dyslipidemia, insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized as a component of the metabolic syndrome. Management depends on symptoms or the source of androgen excess. Several treatment options are available, which allows for an individualized approach. Spironolactone is the safest potent available antiandrogen. It is effective in lowering the hirsutism score by approximately one third, although considerable individual variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase insulin sensitivity, but their mechanism of action differ.
Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be linked with insulin resistance.
The investigators want to measure serum complement, homocysteine and hs-CRP levels in patients with PCOS before and after three-month course of treatment with Cyproterone compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cyproterone compound + Spironolactone | Active comparator | Drug: Cyproterone compound + SpironolactoneCyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily |
| Metformin | Active comparator | Drug: MetforminMetformin 1500 mg daily |
| Pioglitazone | Active comparator | Drug: PioglitazonePioglitazone 30 mg daily |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-35 years
- Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):
Key exclusion criteria (12 listed)
- Smoking
- Pregnancy
- Diabetes mellitus
- Renal failure (serum creatinine >1.5)
- Congenital adrenal hyperplasia
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 |
|---|---|---|
| Cyproterone compound + SpironolactoneAlso: CC-SCyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily | Drug | Cyproterone compound + Spironolactone |
| MetforminMetformin 500mg three times daily | Drug | Metformin |
| PioglitazonePioglitazone 30mg once daily | Drug | Pioglitazone |
Primary outcome
Serum C3 level
Time frame: 3 months
Serum concentration of a component of complement cascade: C3
Serum C4 level
Time frame: 3 months
Serum concentration of a component of complement cascade: C4
Serum high-sensitive CRP (C-reactive protein)
Time frame: 3 months
Serum concentration of high-sensitive C-reactive protein (hs-CRP)
9 secondary outcomes
Serum total Testosterone level
Time frame: 3 months
Serum free Testosterone level
Time frame: 3 months
Serum Dehydroepiandrosterone sulfate (DHEAS) level
Time frame: 3 months
Serum follicle stimulating hormone (FSH) level
Time frame: 3 months
Serum luteinizing hormone (LH) level
Time frame: 3 months
Fasting Blood Sugar (FBS)
Time frame: 3 months
Fasting Serum Insulin level
Time frame: 3 months
Serum homocysteine level
Time frame: 3 months
Number of patients with adverse events
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 12 Nov 2019.
- Individual participant dataSharing planned: No
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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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.
Mesbah Shams, MD principal investigator
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Gholamhossein R Omrani, MD study chair
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cyproterone compound + Spironolactone, Metformin and Pioglitazone in people with Polycystic Ovary Syndrome, run by Shiraz University of Medical Sciences 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 5 inclusion and 12 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 12 Nov 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Serum C3 level (time frame: 3 months). The study lists 3 primary outcomes in all. 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 12 Nov 2019.