Effects of Metformin and Oral Hormonal Contraceptive in Adolescents With Polycystic Ovary Syndrome

NCT00988078 | Unknown DMC

• 1 other identifier: CEP 2102/08
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The polycystic ovary syndrome is the most common endocrinopathy in reproductive age women. The pathophysiology of this syndrome remains unclear, but there are evidences that a decreased in insulin sensitivity may be related in this syndrome. There are studies that showed the action of factors on the sensitivity of the insulin receptor, such as melatonin. It is a hormone produced by the pineal gland, whose role is still uncertain in human reproduction, although many studies have found that it may relate sex hormone effect. Many patients with polycystic ovary syndrome (PCOS) may have hyperinsulinemia, and that pinealectomized rats determined hypoglycemia and hyperinsulinemia, with reduced release of insulin in response to glucose. Therefore, it is supposed that blood levels of melatonin might correlate with the blood insulin concentration in patients with the syndrome. Moreover, the insulin sensitizing agents have been used in the treatment of patients with insulin resistance and PCOS, based on its main pathophysiological substrate which is the hyperinsulinemia. In fact, the metformin is the most used in the literature. However, there are few studies on the use of metformin in adolescents. The evidences of this drugs in this group of patients have showed good therapeutic response with few side effects. The objective of the study is to evaluate the effects of metformin on insulin resistance and levels of melatonin in adolescents with PCOS. It will be performed a prospective, randomized, double-blind and placebo-controlled study with 90 adolescents with PCOS. It will be evaluated clinical and laboratory parameters (TSH, free T4, prolactin, FSH, LH, estradiol, total testosterone, androstenedione, DHEA-s, 17-OH progesterone, SHBG, free androgen index, index of HOMA-IR and QUICKI from fasting glucose and insulin, total cholesterol and fractions, triglycerides, creatinine, AST and ALT and creatinkinase, fibrinogen and PAI-1, and melatonin for 6 months of treatment.

Conditions

Polycystic Ovary Syndrome

Keywords

metformin; Hyperandrogenism; Metabolic Syndrome X; adolescents; melatonin; Polycystic Ovary Syndrome; Insulin Resistance; Menstrual Cycle

Outcome Measures

Primary Outcomes (1)

• serum melatonin

  0 and 6 months

Secondary Outcomes (1)

• hormonal and metabolic measurements, clinical assessment

  0, 3 and 6 months

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin 500mg three times a day for six months

Drug: Metformin

Placebo

PLACEBO COMPARATOR

1 capsule three times a day for six months

Drug: Placebo

Interventions

Placebo DRUG

Capsule (without biologic action) administered three times a day for six months

Placebo

Metformin DRUG

Metformin 500mg three times a day for six months

Metformin

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients until 19 years-old, at least 2 years after menarche
• Patients with Polycystic Ovary Syndrome based on Rotterdan criteries

You may not qualify if:

• Patients with Diabetes Mellitus, hypertension, hyperprolactinemia, adrenal enzymatic deficiency, Cushing syndrome, thyroidopathy, renal or hepatic disfunction
• Use of OC or insulin-sensitising drugs in the last 90 days before
• Pregnancy
• Androgen tumors, hormonal-sensitive tumors in the past
• Contra-indication to the medications used in the study

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Metabolic Syndrome; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jose Maria Soares Junior

  Federal University os Sao Paulo

  STUDY DIRECTOR

• Alexandre Rossi

  Federal University os Sao Paulo

  STUDY CHAIR

• Eduardo Leme Alves da Motta

  Federal University os Sao Paulo

  STUDY DIRECTOR

• Margareth Chiharu Iwata

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margareth Iwata

CONTACT

55-11-24786169; megiwata@yahoo.com

Valeria Secretaria

CONTACT

55-11-55793321; valeria.gineco@epm.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduation

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: July 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 26, 2012

Record last verified: 2009-10

Locations

BR (1)