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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Drospirenone; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Polyestradiol phosphate

Criteria

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