Polycystic Ovary SyndromePhase 3NCT01581814
Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
A Phase 3 study testing Metformin, Yasmin; and Metformin plus Yasmin in people with Polycystic Ovary Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin, Yasmin; and Metformin plus Yasmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2008to Mar 2012
- Phase
- Phase 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-35
- hyperinsulinemic PCOS
Who cannot join
- chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, antiandrogens, drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients
Read the detailed description
Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the present study was to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patients
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Yasmin;, Metformin plus Yasmin
- Keywords
- 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.
MetforminDrug
500 mg of Metformin per 3/die
Yasmin;Drug
1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days)
Metformin plus YasminDrug
0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | 31 subjects were randomized to receive 500 mg Metformin per 3/die Receives: Drug: Metformin |
| 0.03 mg EE plus 3 mg of DRPS | Active comparator | Not described Receives: Drug: Yasmin; |
| Metformin plus Yasmin | Active comparator | Not described Receives: Drug: Metformin plus Yasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4+CD28null frequency
Measured: five minutes
Secondary outcomes (1)
the area under the curve for insulin (AUCi) and lipid profile.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startOct 2008
- Primary completionJul 2011
- Study completionMar 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanna Apa, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581814
- Sponsor's protocol ID
- disfunzionale14
- Status last verified
- Apr 2012
- First submitted
- 19 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Baca M, Pazzano V, Gangale MF, Tropea A, Crea F. CD4+CD28 null T lymphocytes are expanded in young women with polycystic ovary syndrome. Fertil Steril. 2011 Jun 30;95(8):2651-4. doi: 10.1016/j.fertnstert.2011.01.129. Epub 2011 Feb 16.
PubMed 21324454
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01581814
- Acronym / sponsor ID
- disfunzionale14
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Apr 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.
To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients
Detailed description
Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the present study was to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin31 subjects were randomized to receive 500 mg Metformin per 3/die |
| 0.03 mg EE plus 3 mg of DRPS | Active comparator | Drug: Yasmin; |
| Metformin plus Yasmin | Active comparator | Drug: Metformin plus Yasmin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-35
- hyperinsulinemic PCOS
Key exclusion criteria (1 listed)
- chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, antiandrogens, drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).
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 |
|---|---|---|
| Metformin500 mg of Metformin per 3/die | Drug | Metformin |
| Yasmin;1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days) | Drug | 0.03 mg EE plus 3 mg of DRPS |
| Metformin plus Yasmin0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily | Drug | Metformin plus Yasmin |
Primary outcome
CD4+CD28null frequency
Time frame: five minutes
1 secondary outcome
the area under the curve for insulin (AUCi) and lipid profile.
Time frame: 120 minutes
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 20 Apr 2012.
- Results publication: PubMed 21324454Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Baca M, Pazzano V, Gangale MF, Tropea A, Crea F. CD4+CD28 null T lymphocytes are expanded in young women with polycystic ovary syndrome. Fertil Steril. 2011 Jun 30;95(8):2651-4. doi: 10.1016/j.fertnstert.2011.01.129. Epub 2011 Feb 16.
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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 3 study testing Metformin, Yasmin; and Metformin plus Yasmin in people with Polycystic Ovary Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 20 Apr 2012. 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 Italy. 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?
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?
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?
CD4+CD28null frequency (time frame: five minutes). 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 NCT01581814, 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 20 Apr 2012.