Effects of Melatonin in PCOS Women

Catholic University of the Sacred Heart40 enrolled

Overview

The aim of our study is to investigate the effects of a treatment with melatonin on clinical, endocrine and metabolic features in women affected by PCOS. The study group included 40 patients treatend with 2 mg of melatonin daily for six months. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular count, an oral glucose tollerance test and hormonal assays are evaluated before and after therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

MelatoninDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * women with PCOS in accordance with Rotterdam criteria Exclusion Criteria: * pregnancy * past history of cardiovascular diseases * diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) * hypertension * significant liver or renal impairment * other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal) * neoplasms

Locations (1)

Catholic university of Sacred Heart

Rome, Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

Number of cycles in six months of therapy

Time frame: 6 months

Secondary Outcomes

hirsutism score

Ferriman Gallwey score

Time frame: 6 months

testosterone levels

Time frame: 6 months

insulin levels

Time frame: 6 months

total cholesterol

Time frame: 6 months

HDL cholesterol

Time frame: 6 months

LDL cholesterol

Time frame: 6 months

tryglycerides

Time frame: 6 months

androstenedione levels

Time frame: 6 months

free androgen index

Time frame: 6 months

AMH levels

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.