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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01581814
First received: April 19, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
 Drug: Metformin
Drug: Yasmin;
Drug: Metformin plus Yasmin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • CD4+CD28null frequency [ Time Frame: five minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the area under the curve for insulin (AUCi) and lipid profile. [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 99
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581814

Locations
Italy
Policlinico A. Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

Publications:

Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01581814     History of Changes
Other Study ID Numbers: disfunzionale14
Study First Received: April 19, 2012
Last Updated: April 19, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by Catholic University of the Sacred Heart:
PCOS

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
 Endocrine System Diseases
Metformin
Drospirenone and ethinyl estradiol combination
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013