Melatonin Effects on Genital Herpes in Brazilian Women

NCT03831165 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 1215208
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Genital Herpes

Keywords

acyclovir; melatonin

Outcome Measures

Primary Outcomes (1)

• Clinical disease activity

  Number of participants with clinical signals of herpes genial activity

  2 years

Study Arms (3)

melatonin 3mg + Acyclovir 400mg

EXPERIMENTAL

Group I - melatonin 3mg + Acyclovir 400mg

Combination Product: Melatonin 3 mg; Drug: Acyclovir

Acyclovir 400mg

ACTIVE COMPARATOR

Group II - Acyclovir 400mg twice a day

Combination Product: Melatonin 3 mg; Drug: Acyclovir

placebo + melatonin 3mg

PLACEBO COMPARATOR

Group III - placebo + melatonin 3mg

Combination Product: Melatonin 3 mg; Drug: Acyclovir

Interventions

Melatonin 3 mg COMBINATION_PRODUCT

melatonin and placebo

Acyclovir 400mg; melatonin 3mg + Acyclovir 400mg; placebo + melatonin 3mg

Acyclovir DRUG

Only acyclovir 200 mg twice a day

Acyclovir 400mg; melatonin 3mg + Acyclovir 400mg; placebo + melatonin 3mg

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• immunodeficiencies
• pregnant women

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar

São Paulo, São Paulo, 05403000, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Melatonin; Acyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Guanine; Hypoxanthines; Purinones; Purines

Study Officials

• Edmund C Baracat, PhD

  Universidade de Sao Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: February 5, 2019
• Study Start: September 2, 2015
• Primary Completion: September 1, 2021
• Study Completion: December 28, 2021
• Last Updated: January 11, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)