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Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511822
First Posted: January 19, 2012
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
  Purpose

Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms.

The primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers, explaining the frequent association of PCOS with these metabolic conditions. Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It results in an increase in free, biologically active androgens which are related to clinical signs such as hirsutism, acne, seborrhea, and alopecia.

Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely used in this group of patients providing clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain.

More recent studies outlined a deficiency in myo-inositol in women with PCOS and insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle trafficking, and chromatin remodeling. It is a precursor in the synthesis of phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.

It has been reported that the administration of myo-inositol reduces serum insulin, decreases serum testosterone and enhances ovulation.

Due to the different beneficial actions, the aim of the present study is to evaluate the clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin resistance.


Condition Intervention Phase
PCOS Polycystic Ovary Syndrome Drug: Drospirenone Ethinyl estradiol Drug: Drospirenone Ethinyl estradiol Myo-inositol Drug: placebo Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:
  • Score acne (acne grading system by Cook et al)
  • Score hirsutism (Ferriman-Gallwey classification)
  • Measurement of sex hormones in serum
  • Oral glucose tolerance test (OGTT)
  • Measurement of blood glucose and insulin levels
  • BMI

Secondary Outcome Measures:
  • Number of patients with adverse effects

Arms Assigned Interventions
Active Comparator: Drospirenone + Ethinyl estradiol Drug: Drospirenone Ethinyl estradiol
Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months)
Experimental: Drospirenone + Ethinyl estradiol + Myo-inositol Drug: Drospirenone Ethinyl estradiol Myo-inositol
Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months
Placebo Comparator: Placebo Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Women fulfilled two out of three diagnostic criteria for PCOS, according to the 2003 Rotterdam Consensus conference
  • Women with PCOS, insulin resistance, acne, hirsutism and seborrhea

Exclusion Criteria:

  • Women with pre-existing secondary endocrine disorders
  • Women wishing to conceive during the next 12 months
  • Women with contradictions to oral contraceptive use
  • Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
  • Women who received treatment with oral contraceptives, or other drugs for the previous 6 months before entering the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511822


Locations
Italy
Istituto di Patologia Ostetrica e Ginecologica
Catania, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

Publications:
Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01511822     History of Changes
Other Study ID Numbers: Dros_Myo2012
First Submitted: January 11, 2012
First Posted: January 19, 2012
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
PCOS
Insulin resistance
Hyperandrogenism
Myo-inositol

Additional relevant MeSH terms:
Syndrome
Insulin Resistance
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Drospirenone and ethinyl estradiol combination
Inositol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents