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Melatonin Effects on Genital Herpes in Brazilian Women

Primary Purpose

Genital Herpes

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Melatonin 3 mg
Acyclovir
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes focused on measuring acyclovir, melatonin

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • clinical and laboratory diagnosis of genital herpes
  • real time polymerase chain reaction for herpes type 2
  • serology

Exclusion criteria:

  • immunodeficiencies
  • pregnant women

Sites / Locations

  • Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

melatonin 3mg + Acyclovir 400mg

Acyclovir 400mg

placebo + melatonin 3mg

Arm Description

Group I - melatonin 3mg + Acyclovir 400mg

Group II - Acyclovir 400mg twice a day

Group III - placebo + melatonin 3mg

Outcomes

Primary Outcome Measures

Clinical disease activity
Number of participants with clinical signals of herpes genial activity

Secondary Outcome Measures

Full Information

First Posted
July 3, 2018
Last Updated
January 5, 2022
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03831165
Brief Title
Melatonin Effects on Genital Herpes in Brazilian Women
Official Title
Effects of Melatonin in the Treatment of Genital Herpes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2015 (Actual)
Primary Completion Date
September 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Genital herpes is a common and increasingly-common infection worldwide. The annual incidence in the United States is 1.75 per 1000 inhabitants. The etiologic agent is the herpes type 1 and 2 strains simplex virus. Classical Treatment is with acyclovir which decreases the duration of the disease and prevents rashes but has no curative effect. Also, studies show herpes resistance to acyclovir which has stimulating research into new drugs to treat this condition. Authors suggest melatonin way be a therapeutic agent in herpetic disease due to its modulatory action in immune and inflammatory responses when administered in adequate doses. Therefore, the aim of this study is to evaluate the effects of melatonin in the treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective and randomized, investigation. Outcome measures will include clinical evaluation of patients and laboratory endpoints.
Detailed Description
The authors have investigate the relationship of estrogen-dependent malignant tumors with reduced levels of melatonin. It is speculated that the indoleamine can be classified as anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and by its interference with estrogen receptors. Experimentally melatonin prevents promotion and growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor; increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase activity in tumor cells .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
Keywords
acyclovir, melatonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
The patients will be divided into three groups. One group (group A) will receive a bottle with 360 pills of acyclovir 200 mg. These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days. Group B will receive 90 tablets of 30 mg of melatonin, the tablet will be used as 01 tablet daily for 90 days. Group C will receive 90 tablets of melatonin 3mg, and 360 tablets of acyclovir dose is 1 tablet per day for 90 days.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The patients will be treated at the Clinic of Gynecology, University of Sao Paulo during a total of 04 visits. In the first and fourth visits, patients will be sent to the laboratory of the University Hospital for collecting the cluster of differentiation 4 cells, interleukin-2 and serology for herpes.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
melatonin 3mg + Acyclovir 400mg
Arm Type
Experimental
Arm Description
Group I - melatonin 3mg + Acyclovir 400mg
Arm Title
Acyclovir 400mg
Arm Type
Active Comparator
Arm Description
Group II - Acyclovir 400mg twice a day
Arm Title
placebo + melatonin 3mg
Arm Type
Placebo Comparator
Arm Description
Group III - placebo + melatonin 3mg
Intervention Type
Combination Product
Intervention Name(s)
Melatonin 3 mg
Intervention Description
melatonin and placebo
Intervention Type
Drug
Intervention Name(s)
Acyclovir
Intervention Description
Only acyclovir 200 mg twice a day
Primary Outcome Measure Information:
Title
Clinical disease activity
Description
Number of participants with clinical signals of herpes genial activity
Time Frame
2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female only
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: clinical and laboratory diagnosis of genital herpes real time polymerase chain reaction for herpes type 2 serology Exclusion criteria: immunodeficiencies pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund C Baracat, PhD
Organizational Affiliation
Universidade de Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Melatonin Effects on Genital Herpes in Brazilian Women

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