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

This study is currently recruiting participants.

Verified May 2012 by Catholic University of the Sacred Heart

Sponsor:

Information provided by (Responsible Party):

Rosanna Apa, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT01603745

First received: May 19, 2012

Last updated: May 21, 2012

Last verified: May 2012

History of Changes

Purpose

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:

MedlinePlus related topics: Polycystic Ovary Syndrome

Drug Information available for: Estradiol Ethinyl Estradiol Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate Drospirenone

U.S. FDA Resources

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.

Eligibility

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

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603745

Locations

Italy
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

Publications:

Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Bacà 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. Epub 2011 Feb 16.

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:

PCOS

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Estradiol
Ethinyl Estradiol

Drospirenone
Drospirenone and ethinyl estradiol combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Aldosterone Antagonists
Hormone Antagonists
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

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