Effects of Melatonin in PCOS Women

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of 6 Months of Melatonin Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02663570
• Other study ID #: Melatonina15
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: December 3, 2016
• Start date: June 2015

Study information

• Verified date: December 2016
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Catholic University of Sacred heart
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Melatonin

Locations

Country	Name	City	State
Italy	Catholic university of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cycles in six months of therapy		6 months	No
Secondary	hirsutism score	Ferriman Gallwey score	6 months	No
Secondary	testosterone levels		6 months	No
Secondary	insulin levels		6 months	No
Secondary	total cholesterol		6 months	No
Secondary	HDL cholesterol		6 months	No
Secondary	LDL cholesterol		6 months	No
Secondary	tryglycerides		6 months	No
Secondary	androstenedione levels		6 months	No
Secondary	free androgen index		6 months	No
Secondary	AMH levels		6 months	No