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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Estro-progestin Drugs
• Interventions: Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol; Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

• Registration Number: NCT01519401
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-26
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 mg drospirenone and 20 µg ethinyl-estradiol	3 mg drospirenone and 20 µg ethinyl-estradiol	-
3 mg drospirenone and 30 µg ethinyl-estradiol	3 mg drospirenone and 30 µg ethinyl-estradiol	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy