Polycystic Ovary SyndromePhase 2/3PSANCT00955058
Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
A Phase 2/3 study testing OCP in people with Polycystic Ovary Syndrome, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound. Read more about this study
- Who is it for?
- Ages 22 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- OCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Feb 2007to Dec 2010
- Phase
- Phase 2/3
- 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 22 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS patients
Who cannot join
- Women who received hormone therapy during the last 3 months,
- On a diet
- Herbal treatment
- Hyperprolactinemia
- Thyroid disorders
- Ovarian tumors
- Cushing disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.
Read the detailed description
The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.
This randomized clinical trial included 60 polycystic ovary syndrome patients with hirsutism who were referred to infertility and reproductive health research center and governmental public educational hospital from Feb2007 till Dec 2007. Polycystic ovary syndrome was defined as the diagnostic criteria of 2003 census Rotterdam. Hirsutism was defined as the presence of excessive hair in body and Ferriman -Gallway scores more than 7. Women who received hormone therapy during the last 3 months, on a diet or herbal treatment were excluded from the study. The other exclusion criterion's consisted of Hyperprolactinemia, thyroid disorders, ovarian tumors and Cushing disease. Hirsutism was determined by the Ferriman-Gallway score and recorded for every patient. Blood samples for serum PSA, and the hormonal profile including free testosterone, dehydroepiandrostenedione sulfate(DHEAS) and 17-hydroxyprogesterone(17-OHP) were taken at baseline and at the end of the treatment at the early follicular phase between 3th to 5th days of menstrual cycle at 8 AM. Patients were divided randomly in two treatment groups according to the computer based table. one group received oral contraceptive pills and the other one received cyproterone acetate combined ethinyl-estradiol(Diane) for 3 months. Hirsutism score was evaluated after treatment again. The blood samples were taken during the early follicular phase after 3 months of treatment to avoid pharmacological effect of treatment and serum PSA, free testosterone, DHEAS,17-OHP were measured again. The university ethics committee approved the study and the informed consent was obtained from patients.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- OCP
- Keywords
- PSA, PCO, PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCPDrug
Daily For 3 months
| Study group | Role | What they receive |
|---|---|---|
| cyproterone compound | Active comparator | Before and after treatment Receives: Drug: OCP |
| oral contraceptive pill | Experimental | Treatment Receives: Drug: OCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay
Measured: 3 MONTHS
Secondary outcomes (1)
Serum free testosterone was measured by ELISA and 17OHP and DHEAS were measured by radio-immunoassay and gamma scan test.
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 posted7 Aug 2009 (estimated)
- Study startFeb 2007
- Primary completionFeb 2007 (estimated)
- Study completionDec 2010 (estimated)
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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955058
- Sponsor's protocol ID
- PSA
- Acronym
- PSA
- Status last verified
- Sep 2009
- First submitted
- 4 Aug 2009
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
- ClinicalTrials.gov ID
- NCT00955058
- Acronym / sponsor ID
- PSA / PSA
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PSA, PCO, PCOS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2007 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 7 Aug 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 evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.
Detailed description
The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.
This randomized clinical trial included 60 polycystic ovary syndrome patients with hirsutism who were referred to infertility and reproductive health research center and governmental public educational hospital from Feb2007 till Dec 2007. Polycystic ovary syndrome was defined as the diagnostic criteria of 2003 census Rotterdam. Hirsutism was defined as the presence of excessive hair in body and Ferriman -Gallway scores more than 7. Women who received hormone therapy during the last 3 months, on a diet or herbal treatment were excluded from the study. The other exclusion criterion's consisted of Hyperprolactinemia, thyroid disorders, ovarian tumors and Cushing disease. Hirsutism was determined by the Ferriman-Gallway score and recorded for every patient. Blood samples for serum PSA, and the hormonal profile including free testosterone, dehydroepiandrostenedione sulfate(DHEAS) and 17-hydroxyprogesterone(17-OHP) were taken at baseline and at the end of the treatment at the early follicular phase between 3th to 5th days of menstrual cycle at 8 AM. Patients were divided randomly in two treatment groups according to the computer based table. one group received oral contraceptive pills and the other one received cyproterone acetate combined ethinyl-estradiol(Diane) for 3 months. Hirsutism score was evaluated after treatment again. The blood samples were taken during the early follicular phase after 3 months of treatment to avoid pharmacological effect of treatment and serum PSA, free testosterone, DHEAS,17-OHP were measured again. The university ethics committee approved the study and the informed consent was obtained from patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyproterone compound | Active comparator | Drug: OCPBefore and after treatment |
| oral contraceptive pill | Experimental | Drug: OCPTreatment |
Who may qualify
- Ages
- 22 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PCOS patients
Key exclusion criteria (7 listed)
- Women who received hormone therapy during the last 3 months,
- On a diet
- Herbal treatment
- Hyperprolactinemia
- Thyroid disorders
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 |
|---|---|---|
| OCPDaily For 3 months | Drug | cyproterone compound, oral contraceptive pill |
Primary outcome
Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay
Time frame: 3 MONTHS
1 secondary outcome
Serum free testosterone was measured by ELISA and 17OHP and DHEAS were measured by radio-immunoassay and gamma scan test.
Time frame: 3 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OCP in people with Polycystic Ovary Syndrome, run by Shahid Beheshti University 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 1 inclusion and 7 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 3 Sep 2009. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay (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 3 Sep 2009.