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

NCT ID: NCT01603745

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NOMAC-valerate estradiol

E/P therapy

Group Type: ACTIVE_COMPARATOR

Zoely

Intervention Type: DRUG

1 pill every day

Drospirenone/ethinylestradiol

E/P therapy

Group Type: ACTIVE_COMPARATOR

Yasmin

Intervention Type: DRUG

1 pill every day

Interventions

Zoely

1 pill every day

Intervention Type: DRUG

Yasmin

1 pill every day

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Rosanna Apa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic university of Sacred Heart

Rome, Rome, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Rosanna Apa, MD

Role: primary

sandrina84@hotmail.com

References

Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Baca 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. doi: 10.1016/j.fertnstert.2011.01.129. Epub 2011 Feb 16.

Reference Type: RESULT

PMID: 21324454 (View on PubMed)

Other Identifiers

zoely1984

Identifier Type: -

Identifier Source: org_study_id