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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01519401

Enrollment

Registered

2012-01-26

Start date

2010-02-28

Completion date

2011-07-31

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Estro-progestin Drugs, Polycystic Ovary Syndrome

Keywords

PCOS, drospirenone ethinylestradiol, androgens, metabolism

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.

Interventions

DRUG3 mg drospirenone and 20 µg ethinyl-estradiol

DRUG3 mg drospirenone and 30 µg ethinyl-estradiol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026