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

Catholic University of the Sacred Heart

Status

Completed

Conditions

Polycystic Ovary Syndrome

Estro-progestin Drugs

Treatments

Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol

Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

Study type

Interventional

Funder types

Other

Identifiers

NCT01519401

000102010

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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