Polycystic Ovary SyndromeNCT01519401
Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
A study testing 3 mg drospirenone and 20 µg ethinyl-estradiol and 3 mg drospirenone and 30 µg ethinyl-estradiol in people with Polycystic Ovary Syndrome and Estro-progestin Drugs, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS). The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg… 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, Estro-progestin Drugs
- What is being tested?
- 3 mg drospirenone and 20 µg ethinyl-estradiol and 3 mg drospirenone and 30 µg ethinyl-estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Jul 2011
- Phase
- Interventional
- 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
- normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.
Who cannot join
- pregnancy
- past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension
- significant liver or renal impairment
- other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
- neoplasms
- unstable mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.
The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).
The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.
- Conditions
- Polycystic Ovary Syndrome, Estro-progestin Drugs
- Being tested
- 3 mg drospirenone and 20 µg ethinyl-estradiol, 3 mg drospirenone and 30 µg ethinyl-estradiol
- Keywords
- PCOS, drospirenone ethinylestradiol, androgens, metabolism
- 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.
3 mg drospirenone and 20 µg ethinyl-estradiolDrug
3 mg drospirenone and 30 µg ethinyl-estradiolDrug
| Study group | Role | What they receive |
|---|---|---|
| 3 mg drospirenone and 20 µg ethinyl-estradiol | Active comparator | Not described Receives: Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol |
| 3 mg drospirenone and 30 µg ethinyl-estradiol | Active comparator | Not described Receives: Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women
hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionJul 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Guido, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519401
- Sponsor's protocol ID
- 000102010
- Status last verified
- Jul 2020
- First submitted
- 23 Jan 2012
- Last updated
- 24 Jul 2020
- Results posted
- No
Publications
Romualdi D, De Cicco S, Busacca M, Gagliano D, Lanzone A, Guido M. Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: a randomized study. J Endocrinol Invest. 2013 Sep;36(8):636-41. doi: 10.1007/BF03346756.
PubMed 24105072
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.
- ClinicalTrials.gov ID
- NCT01519401
- Acronym / sponsor ID
- 000102010
- Conditions
- Polycystic Ovary Syndrome, Estro-progestin Drugs
- Keywords
- PCOS, drospirenone ethinylestradiol, androgens, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 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.
The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).
The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 mg drospirenone and 20 µg ethinyl-estradiol | Active comparator | Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol |
| 3 mg drospirenone and 30 µg ethinyl-estradiol | Active comparator | Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.
Key exclusion criteria (6 listed)
- pregnancy
- past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension
- significant liver or renal impairment
- other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
- neoplasms
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 |
|---|---|---|
| 3 mg drospirenone and 20 µg ethinyl-estradiol | Drug | 3 mg drospirenone and 20 µg ethinyl-estradiol |
| 3 mg drospirenone and 30 µg ethinyl-estradiol | Drug | 3 mg drospirenone and 30 µg ethinyl-estradiol |
Primary outcome
To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women
Time frame: twelve months
hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile
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 24 Jul 2020.
- Derived from this study: PubMed 24105072Romualdi D, De Cicco S, Busacca M, Gagliano D, Lanzone A, Guido M. Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: a randomized study. J Endocrinol Invest. 2013 Sep;36(8):636-41. doi: 10.1007/BF03346756.
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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 study testing 3 mg drospirenone and 20 µg ethinyl-estradiol and 3 mg drospirenone and 30 µg ethinyl-estradiol in people with Polycystic Ovary Syndrome and Estro-progestin Drugs, 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 1 inclusion and 6 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 24 Jul 2020. 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.
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?
To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women (time frame: twelve months). 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 NCT01519401, 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 24 Jul 2020.