PCOSPhase 4NCT01511822
Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance
A Phase 4 study testing Drospirenone Ethinyl estradiol and Drospirenone Ethinyl estradiol Myo-inositol in people with PCOS and Polycystic Ovary Syndrome, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms. The primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PCOS, Polycystic Ovary Syndrome
- What is being tested?
- Drospirenone Ethinyl estradiol and Drospirenone Ethinyl estradiol Myo-inositol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- 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 35 years
- Women only
- Adult
Who may be able to join
- Women fulfilled two out of three diagnostic criteria for PCOS, according to the 2003 Rotterdam Consensus conference
- Women with PCOS, insulin resistance, acne, hirsutism and seborrhea
Who cannot join
- Women with pre-existing secondary endocrine disorders
- Women wishing to conceive during the next 12 months
- Women with contradictions to oral contraceptive use
- Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
- Women who received treatment with oral contraceptives, or other drugs for the previous 6 months before entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms.
The primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers, explaining the frequent association of PCOS with these metabolic conditions. Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It results in an increase in free, biologically active androgens which are related to clinical signs such as hirsutism, acne, seborrhea, and alopecia.
Read more
Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely used in this group of patients providing clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain.
More recent studies outlined a deficiency in myo-inositol in women with PCOS and insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle trafficking, and chromatin remodeling. It is a precursor in the synthesis of phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.
It has been reported that the administration of myo-inositol reduces serum insulin, decreases serum testosterone and enhances ovulation.
Due to the different beneficial actions, the aim of the present study is to evaluate the clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin resistance.
- Conditions
- PCOS, Polycystic Ovary Syndrome
- Being tested
- Drospirenone Ethinyl estradiol, Drospirenone Ethinyl estradiol Myo-inositol, placebo
- Keywords
- PCOS, Insulin resistance, Hyperandrogenism, Myo-inositol
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone Ethinyl estradiolDrug
Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months)
Drospirenone Ethinyl estradiol Myo-inositolDrug
Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Drospirenone + Ethinyl estradiol | Active comparator | Not described Receives: Drug: Drospirenone Ethinyl estradiol |
| Drospirenone + Ethinyl estradiol + Myo-inositol | Experimental | Not described Receives: Drug: Drospirenone Ethinyl estradiol Myo-inositol |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score acne (acne grading system by Cook et al)
Score hirsutism (Ferriman-Gallwey classification)
Measurement of sex hormones in serum
Oral glucose tolerance test (OGTT)
Measurement of blood glucose and insulin levels
BMI
Secondary outcomes (1)
Number of patients with adverse effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511822
- Sponsor's protocol ID
- Dros_Myo2012
- Status last verified
- Jan 2012
- First submitted
- 11 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
Publications
D'Anna R, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. Myo-inositol may prevent gestational diabetes in PCOS women. Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28.
PubMed 22122627Minozzi M, Costantino D, Guaraldi C, Unfer V. The effect of a combination therapy with myo-inositol and a combined oral contraceptive pill versus a combined oral contraceptive pill alone on metabolic, endocrine, and clinical parameters in polycystic ovary syndrome. Gynecol Endocrinol. 2011 Nov;27(11):920-4. doi: 10.3109/09513590.2011.564685. Epub 2011 Mar 21.
PubMed 21417594Mathur R, Levin O, Azziz R. Use of ethinylestradiol/drospirenone combination in patients with the polycystic ovary syndrome. Ther Clin Risk Manag. 2008 Apr;4(2):487-92. doi: 10.2147/tcrm.s6864.
PubMed 18728832
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance
- ClinicalTrials.gov ID
- NCT01511822
- Acronym / sponsor ID
- Dros_Myo2012
- Conditions
- PCOS, Polycystic Ovary Syndrome
- Keywords
- PCOS, Insulin resistance, Hyperandrogenism, Myo-inositol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- First posted
- 19 Jan 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.
Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms.
The primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers, explaining the frequent association of PCOS with these metabolic conditions. Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It results in an increase in free, biologically active androgens which are related to clinical signs such as hirsutism, acne, seborrhea, and alopecia.
Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely used in this group of patients providing clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain.
More recent studies outlined a deficiency in myo-inositol in women with PCOS and insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle trafficking, and chromatin remodeling. It is a precursor in the synthesis of phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.
It has been reported that the administration of myo-inositol reduces serum insulin, decreases serum testosterone and enhances ovulation.
Due to the different beneficial actions, the aim of the present study is to evaluate the clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin resistance.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drospirenone + Ethinyl estradiol | Active comparator | Drug: Drospirenone Ethinyl estradiol |
| Drospirenone + Ethinyl estradiol + Myo-inositol | Experimental | Drug: Drospirenone Ethinyl estradiol Myo-inositol |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women fulfilled two out of three diagnostic criteria for PCOS, according to the 2003 Rotterdam Consensus conference
- Women with PCOS, insulin resistance, acne, hirsutism and seborrhea
Key exclusion criteria (5 listed)
- Women with pre-existing secondary endocrine disorders
- Women wishing to conceive during the next 12 months
- Women with contradictions to oral contraceptive use
- Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
- Women who received treatment with oral contraceptives, or other drugs for the previous 6 months before entering 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 |
|---|---|---|
| Drospirenone Ethinyl estradiolDrospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months) | Drug | Drospirenone + Ethinyl estradiol |
| Drospirenone Ethinyl estradiol Myo-inositolDrospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months | Drug | Drospirenone + Ethinyl estradiol + Myo-inositol |
| placebo | Drug | Placebo |
Primary outcome
Score acne (acne grading system by Cook et al)
Score hirsutism (Ferriman-Gallwey classification)
Measurement of sex hormones in serum
Oral glucose tolerance test (OGTT)
Measurement of blood glucose and insulin levels
BMI
1 secondary outcome
Number of patients with adverse effects
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 19 Jan 2012.
- Background: PubMed 22122627D'Anna R, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. Myo-inositol may prevent gestational diabetes in PCOS women. Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28.
- Background: PubMed 21417594Minozzi M, Costantino D, Guaraldi C, Unfer V. The effect of a combination therapy with myo-inositol and a combined oral contraceptive pill versus a combined oral contraceptive pill alone on metabolic, endocrine, and clinical parameters in polycystic ovary syndrome. Gynecol Endocrinol. 2011 Nov;27(11):920-4. doi: 10.3109/09513590.2011.564685. Epub 2011 Mar 21.
- Background: PubMed 18728832Mathur R, Levin O, Azziz R. Use of ethinylestradiol/drospirenone combination in patients with the polycystic ovary syndrome. Ther Clin Risk Manag. 2008 Apr;4(2):487-92. doi: 10.2147/tcrm.s6864.
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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 4 study testing Drospirenone Ethinyl estradiol and Drospirenone Ethinyl estradiol Myo-inositol in people with PCOS and Polycystic Ovary Syndrome, run by AGUNCO Obstetrics and Gynecology Centre 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 5 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 19 Jan 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. 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?
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?
Score acne (acne grading system by Cook et al). The study lists 6 primary outcomes in all. 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 NCT01511822, which also lists 3 linked publications.
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 19 Jan 2012.