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Effects of Melatonin in PCOS Women

NCT ID: NCT02663570

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open

therapy with melatonin 2 mg daily for six months

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Interventions

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Melatonin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Rosanna Apa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic university of Sacred Heart

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Rosanna Apa, MD

Role: primary

Other Identifiers

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Melatonina15

Identifier Type: -

Identifier Source: org_study_id