Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in 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: NCT01603745
Recruitment Status : Unknown
Verified May 2012 by Rosanna Apa, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart

Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Zoely Drug: Yasmin Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : May 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. cardiovascular risk [ Time Frame: 120 minutes ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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)

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): NCT01603745

Layout table for location information
Catholic university of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Rosanna Apa, MD   
Principal Investigator: Rosanna Apa, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart

Publications of Results:
Layout table for additonal information
Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart Identifier: NCT01603745    
Other Study ID Numbers: zoely1984
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012
Keywords provided by Rosanna Apa, Catholic University of the Sacred Heart:
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents