NCT02663570

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

January 21, 2016

Last Update Submit

December 3, 2016

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of cycles in six months of therapy

    6 months

Secondary Outcomes (10)

  • hirsutism score

    6 months

  • testosterone levels

    6 months

  • insulin levels

    6 months

  • total cholesterol

    6 months

  • HDL cholesterol

    6 months

  • +5 more secondary outcomes

Study Arms (1)

open

EXPERIMENTAL

therapy with melatonin 2 mg daily for six months

Drug: Melatonin

Interventions

MelatoninDRUG
open

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PCOS in accordance with Rotterdam criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic university of Sacred Heart

Rome, Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 26, 2016

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

IT(1)