Back to results

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

Primary Purpose

Polycystic Ovary Syndrome, Estro-progestin Drugs

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

3 mg drospirenone and 20 µg ethinyl-estradiol

3 mg drospirenone and 30 µg ethinyl-estradiol

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, drospirenone ethinylestradiol, androgens, metabolism

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts 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

Sites / Locations

Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

3 mg drospirenone and 20 µg ethinyl-estradiol

3 mg drospirenone and 30 µg ethinyl-estradiol

Arm Description

Outcomes

Primary Outcome Measures

To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women

hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile

Secondary Outcome Measures

Full Information

NCT ID

NCT01519401

First Posted

January 23, 2012

Last Updated

July 22, 2020

Sponsor

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT01519401

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic University of the Sacred Heart

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Estro-progestin Drugs

Keywords

PCOS, drospirenone ethinylestradiol, androgens, metabolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3 mg drospirenone and 20 µg ethinyl-estradiol

Arm Type

Active Comparator

Arm Title

3 mg drospirenone and 30 µg ethinyl-estradiol

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

3 mg drospirenone and 20 µg ethinyl-estradiol

Intervention Type

Drug

Intervention Name(s)

3 mg drospirenone and 30 µg ethinyl-estradiol

Primary Outcome Measure Information:

Title

To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women

Description

hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile

Time Frame

twelve months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Catholic University of Sacred Heart

City

Rome

ZIP/Postal Code

00168

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

24105072

Citation

Romualdi D, De Cicco S, Busacca M, Gagliano D, Lanzone A, Guido M. 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. J Endocrinol Invest. 2013 Sep;36(8):636-41. doi: 10.1007/BF03346756.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs