Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
First received: May 19, 2012
Last updated: May 21, 2012
Last verified: May 2012
Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia, hypertension, oxidative stress and inflammation are associated with PCOS. The investigators want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in PCOS.

Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Zoely
Drug: Yasmin
Phase 1

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • cardiovascular risk [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    total testosterone (T), SHBG, androstenedione (A), 17-hydroxyprogesterone (17-OHP), dehydroepiandrosterone sulphate (DHEAS), triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol (HDL and LDL cholesterol) and alanine aminotransferase (ALT),CD4+CD28null frequency

Estimated Enrollment: 10
Study Start Date: April 2012
Estimated Study Completion Date: October 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NOMAC-valerate estradiol
E/P therapy
Drug: Zoely
1 pill every day
Active Comparator: Drospirenone/ethinylestradiol
E/P therapy
Drug: Yasmin
1 pill every day

Detailed Description:
PCOS is the most common female endocrinopathy in reproductive age. This syndrome is a heterogeneous condition characterized by several symptoms and clinical signs related to reproductive, cardiometabolic and psychological disorders.We recently demonstrated that young PCOS women show an expansion of an unusual T-cell population with proinflammatory functions, identified by CD4+CD28null T lymphocytes . Of note, this T subpopulation has been found to be expanded in patients with unstable angina, type 2 diabetes (DM2), in absence of clinical evidence of CVD 12, and has been recently associated to recurrent coronary instability .Based on the above mentioned evidences, the aim of the present study is 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 patientsTo evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) and NOMAC-valerate estardiol on some cardiovascular risk factors in PCOS patients.

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients with PCOS aged 18-35 years

Exclusion Criteria:

  • chronic or acute inflammatory disease
  • cancer
  • autoimmune disease
  • treatment with clomiphene citrate
  • 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01603745

Catholic university of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Rosanna Apa, MD       sandrina84@hotmail.com   
Principal Investigator: Rosanna Apa, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01603745     History of Changes
Other Study ID Numbers: zoely1984 
Study First Received: May 19, 2012
Last Updated: May 21, 2012
Health Authority: Italy: National Institute of Health
United States: Food and Drug Administration

Keywords provided by Catholic University of the Sacred Heart:

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Cysts
Ovarian Diseases
Drospirenone and ethinyl estradiol combination
Ethinyl Estradiol
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 26, 2016