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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01519401
First received: January 23, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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 Intervention
Polycystic Ovary Syndrome
Estro-progestin Drugs
 Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol
Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
    hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile


Study Start Date: February 2010
Study Completion Date: July 2011
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519401

Locations
Italy
Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Maurizio Guido, medical doctor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01519401     History of Changes
Other Study ID Numbers: 000102010
Study First Received: January 23, 2012
Last Updated: January 23, 2012
Health Authority: Italy: Catholic University of Sacred Heart

Keywords provided by Catholic University of the Sacred Heart:
PCOS
drospirenone ethinylestradiol
androgens
metabolism

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Drospirenone
Estradiol valerate
 Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013