Back to results

Effects of Melatonin in PCOS Women

Primary Purpose

Polycystic Ovary Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Melatonin

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Catholic university of Sacred HeartRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open

Arm Description

therapy with melatonin 2 mg daily for six months

Outcomes

Primary Outcome Measures

Number of cycles in six months of therapy

Secondary Outcome Measures

hirsutism score

Ferriman Gallwey score

testosterone levels

insulin levels

total cholesterol

HDL cholesterol

LDL cholesterol

tryglycerides

androstenedione levels

free androgen index

AMH levels

Full Information

NCT ID

NCT02663570

First Posted

January 21, 2016

Last Updated

December 3, 2016

Sponsor

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT02663570

Brief Title

Effects of Melatonin in PCOS Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic University of the Sacred Heart

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

open

Arm Type

Experimental

Arm Description

therapy with melatonin 2 mg daily for six months

Intervention Type

Drug

Intervention Name(s)

Melatonin

Primary Outcome Measure Information:

Title

Number of cycles in six months of therapy

Time Frame

6 months

Secondary Outcome Measure Information:

Title

hirsutism score

Description

Ferriman Gallwey score

Time Frame

6 months

Title

testosterone levels

Time Frame

6 months

Title

insulin levels

Time Frame

6 months

Title

total cholesterol

Time Frame

6 months

Title

HDL cholesterol

Time Frame

6 months

Title

LDL cholesterol

Time Frame

6 months

Title

tryglycerides

Time Frame

6 months

Title

androstenedione levels

Time Frame

6 months

Title

free androgen index

Time Frame

6 months

Title

AMH levels

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Catholic university of Sacred Heart

City

Rome

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rosanna Apa, MD

krimisa@libero.it

First Name & Middle Initial & Last Name & Degree

Rosanna Apa, MD

12. IPD Sharing Statement

Learn more about this trial

Effects of Melatonin in PCOS Women

We'll reach out to this number within 24 hrs