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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT01519401

Collaborator

(none)

Enrollment

Location

Arms

16.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Estro-progestin Drugs	Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3 mg drospirenone and 20 µg ethinyl-estradiol	Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol
Active Comparator: 3 mg drospirenone and 30 µg ethinyl-estradiol	Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

Arm

Intervention/Treatment

Active Comparator: 3 mg drospirenone and 20 µg ethinyl-estradiol

Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol

Active Comparator: 3 mg drospirenone and 30 µg ethinyl-estradiol

Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

Outcome Measures

Primary Outcome Measures

To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women [twelve months]
hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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