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

NCT01519401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-07-24

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519401 on ClinicalTrials.gov