Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
1 other identifier
interventional
99
1 country
1
Brief Summary
To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedApril 20, 2012
April 1, 2012
2.7 years
April 19, 2012
April 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CD4+CD28null frequency
five minutes
Secondary Outcomes (1)
the area under the curve for insulin (AUCi) and lipid profile.
120 minutes
Study Arms (3)
Metformin
ACTIVE COMPARATOR31 subjects were randomized to receive 500 mg Metformin per 3/die
0.03 mg EE plus 3 mg of DRPS
ACTIVE COMPARATORMetformin plus Yasmin
ACTIVE COMPARATORInterventions
1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days)
0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily
Eligibility Criteria
You may qualify if:
- age 18-35
- hyperinsulinemic PCOS
You may not qualify if:
- chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, 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)
Policlinico A. Gemelli
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)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 20, 2012
Study Start
October 1, 2008
Primary Completion
July 1, 2011
Study Completion
March 1, 2012
Last Updated
April 20, 2012
Record last verified: 2012-04