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Trial record 34 of 98 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01581814
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : April 20, 2012
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart

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

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Yasmin; Drug: Metformin plus Yasmin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Metformin
31 subjects were randomized to receive 500 mg Metformin per 3/die
Drug: Metformin
500 mg of Metformin per 3/die

Active Comparator: 0.03 mg EE plus 3 mg of DRPS Drug: Yasmin;
1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days)

Active Comparator: Metformin plus Yasmin Drug: Metformin plus Yasmin
0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily

Primary Outcome Measures :
  1. CD4+CD28null frequency [ Time Frame: five minutes ]

Secondary Outcome Measures :
  1. the area under the curve for insulin (AUCi) and lipid profile. [ Time Frame: 120 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581814

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Policlinico A. Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Publications of Results:
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Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart Identifier: NCT01581814    
Other Study ID Numbers: disfunzionale14
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012
Keywords provided by Rosanna Apa, Catholic University of the Sacred Heart:
Additional relevant MeSH terms:
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Drospirenone and ethinyl estradiol combination
Ethinyl Estradiol
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Hormones, Hormone Substitutes, and Hormone Antagonists