Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.

Polycystic Ovary Syndrome Clinical Trial

Official title:

Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519401
• Other study ID #: 000102010
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2020
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).

The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.

Exclusion Criteria:

• pregnancy

• past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension

• significant liver or renal impairment

• other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)

• neoplasms

• unstable mental illness

Related Conditions & MeSH terms

• Estro-progestin Drugs
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• 3 mg drospirenone and 20 µg ethinyl-estradiol

• 3 mg drospirenone and 30 µg ethinyl-estradiol

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women	hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile	twelve months