MedDataX Logo

Melatonin Effects on Genital Herpes in Brazilian Women

NCT ID: NCT03831165

Last Updated: 2022-01-11

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-02

Study Completion Date

2021-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

NCT01327144

Herpes Zoster
COMPLETED PHASE3

Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

NCT00297011

Herpes Labialis
COMPLETED PHASE2

Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease

NCT00699764

Herpes Simplex
COMPLETED PHASE3

Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth

NCT00031447

Herpes Simplex
COMPLETED PHASE3

Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)

NCT00371592

HIV Infections Herpesvirus 2, Human
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Genital Herpes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

melatonin 3mg + Acyclovir 400mg

Group I - melatonin 3mg + Acyclovir 400mg

Group Type EXPERIMENTAL

Melatonin 3 mg

Intervention Type COMBINATION_PRODUCT

melatonin and placebo

Acyclovir

Intervention Type DRUG

Only acyclovir 200 mg twice a day

Acyclovir 400mg

Group II - Acyclovir 400mg twice a day

Group Type ACTIVE_COMPARATOR

Melatonin 3 mg

Intervention Type COMBINATION_PRODUCT

melatonin and placebo

Acyclovir

Intervention Type DRUG

Only acyclovir 200 mg twice a day

placebo + melatonin 3mg

Group III - placebo + melatonin 3mg

Group Type PLACEBO_COMPARATOR

Melatonin 3 mg

Intervention Type COMBINATION_PRODUCT

melatonin and placebo

Acyclovir

Intervention Type DRUG

Only acyclovir 200 mg twice a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin 3 mg

melatonin and placebo

Intervention Type COMBINATION_PRODUCT

Acyclovir

Only acyclovir 200 mg twice a day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* immunodeficiencies
* pregnant women
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edmund C Baracat, PhD

Role: STUDY_DIRECTOR

Universidade de Sao Paulo General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar

São Paulo, São Paulo, Brazil

Site Status

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

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1215208

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
NCT00306787 COMPLETED PHASE3
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
NCT01281007 COMPLETED PHASE3
Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
NCT00031460 COMPLETED PHASE3
Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis)
NCT00467662 UNKNOWN PHASE4
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
NCT00946556 COMPLETED NA
Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)
NCT00002186 COMPLETED NA
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
NCT01308424 COMPLETED PHASE1/PHASE2
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
NCT00079911 TERMINATED PHASE4
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
NCT00803543 COMPLETED NA
The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
NCT00001054 WITHDRAWN PHASE1
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
NCT00375570 COMPLETED PHASE3
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
NCT00006132 UNKNOWN PHASE3
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
NCT00001115 COMPLETED NA
Herpes Zoster: Risk Factors, Complications and Special Situations
NCT03903237 COMPLETED
SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir
NCT00002310 COMPLETED NA
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
NCT00736437 COMPLETED PHASE2
Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
NCT00697567 COMPLETED PHASE2
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
NCT02837575 COMPLETED PHASE2
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
NCT00224471 COMPLETED PHASE3
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
NCT00005663 UNKNOWN PHASE3
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
NCT00006135 COMPLETED PHASE3
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
NCT00076232 COMPLETED PHASE3
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
NCT01574612 COMPLETED PHASE3
Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
NCT00004757 COMPLETED PHASE3
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
NCT03146403 TERMINATED PHASE2