Effects of Melatonin in PCOS Women

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT02663570

Melatonina15

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

open

Experimental group

Description:

therapy with melatonin 2 mg daily for six months

Treatment:

Drug: Melatonin