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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Margareth Chiharu Iwata, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00988078
First received: September 30, 2009
Last updated: June 24, 2012
Last verified: October 2009
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Drug: Placebo
Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Metformin Therapy on Insulin Resistance and Melatonin in Adolescents With Polycystic Ovary Syndrome.

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • serum melatonin [ Time Frame: 0 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hormonal and metabolic measurements, clinical assessment [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Metformin 500mg three times a day for six months
Drug: Metformin
Metformin 500mg three times a day for six months
Placebo Comparator: Placebo
1 capsule three times a day for six months
Drug: Placebo
Capsule (without biologic action) administered three times a day for six months

Detailed Description:

Design: 90 patients will be selected to a prospective, randomized and double-blinded study. They will be assigned to two groups: A) 45 patients, treated with OC (oral contraceptive) and metformin 1500mg/ day. B) 45 patients, treated with OC and placebo. The length of treatment was six months.

Inclusion criteria: patients until 19 years-old, at least 2 years after menarche, with Polycystic Ovary Syndrome based on Rotterdan criterion. Exclusion criteria: 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.

Clinical parameters included are weight and height (for BMI), waist to hip ratio, habits like smoking or drinking, drug addiction, blood pressure measurement, hirsutism and acne.

Laboratorial parameters included are TSH, free T4, prolactin, FSH, LH, estradiol, total testosterone, androstenedione, s-DHEA, 17-OH progesterone, SHBG, free androgen index, fasting glucose and insulin, total cholesterol and fractions, triglycerides, creatinin, TGO, TGP, CK, PAI-1, fibrinogen, melatonin.

Patients will be evaluated using these parameters in the beginning, 1, 3 and 6 months after use of the drugs.

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988078

Contacts
Contact: Margareth Iwata 55-11-24786169 megiwata@yahoo.com
Contact: Valeria Secretaria 55-11-55793321 valeria.gineco@epm.br

Locations
Brazil
Federal University of Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: Margareth Iwata       megiwata@yahoo.com   
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Jose Maria Soares Junior Federal University os Sao Paulo
Study Chair: Alexandre Rossi Federal University os Sao Paulo
Study Director: Eduardo Leme Alves da Motta Federal University os Sao Paulo
Principal Investigator: Margareth Chiharu Iwata Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Margareth Chiharu Iwata, post graduation, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00988078     History of Changes
Other Study ID Numbers: CEP 2102/08
Study First Received: September 30, 2009
Last Updated: June 24, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
metformin
Hyperandrogenism
Metabolic Syndrome X
adolescents
melatonin
Polycystic Ovary Syndrome
Insulin Resistance
Menstrual Cycle

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014