Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 19, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMay 22, 2012
May 1, 2012
1 month
May 19, 2012
May 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cardiovascular risk
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
120 minutes
Study Arms (2)
NOMAC-valerate estradiol
ACTIVE COMPARATORE/P therapy
Drospirenone/ethinylestradiol
ACTIVE COMPARATORE/P therapy
Interventions
Eligibility Criteria
You may qualify if:
- patients with PCOS aged 18-35 years
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic university of Sacred Heart
Rome, Rome, 00168, Italy
Related Publications (1)
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.
PMID: 21324454RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 19, 2012
First Posted
May 22, 2012
Study Start
April 1, 2012
Primary Completion
May 1, 2012
Study Completion
October 1, 2012
Last Updated
May 22, 2012
Record last verified: 2012-05