Back to resultsEffects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Metformin
Yasmin;
Metformin plus Yasmin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS
Eligibility Criteria
Inclusion Criteria:
- age 18-35
- hyperinsulinemic PCOS
Exclusion Criteria:
- 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).
Sites / Locations
- Policlinico A. Gemelli
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Metformin
0.03 mg EE plus 3 mg of DRPS
Metformin plus Yasmin
Arm Description
31 subjects were randomized to receive 500 mg Metformin per 3/die
Outcomes
Primary Outcome Measures
CD4+CD28null frequency
Secondary Outcome Measures
the area under the curve for insulin (AUCi) and lipid profile.
Full Information
NCT ID
NCT01581814
First Posted
April 19, 2012
Last Updated
April 19, 2012
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01581814
Brief Title
Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
31 subjects were randomized to receive 500 mg Metformin per 3/die
Arm Title
0.03 mg EE plus 3 mg of DRPS
Arm Type
Active Comparator
Arm Title
Metformin plus Yasmin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500 mg of Metformin per 3/die
Intervention Type
Drug
Intervention Name(s)
Yasmin;
Intervention Description
1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days)
Intervention Type
Drug
Intervention Name(s)
Metformin plus Yasmin
Intervention Description
0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily
Primary Outcome Measure Information:
Title
CD4+CD28null frequency
Time Frame
five minutes
Secondary Outcome Measure Information:
Title
the area under the curve for insulin (AUCi) and lipid profile.
Time Frame
120 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-35
hyperinsulinemic PCOS
Exclusion Criteria:
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).
Facility Information:
Facility Name
Policlinico A. Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21324454
Citation
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.
Results Reference
result
Learn more about this trial
Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
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