Melatonin Effects on Genital Herpes in Brazilian Women

Status Completed

Clinical Trial 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.

Clinical Trial 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 . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03831165
Study type	Interventional
Source	University of Sao Paulo General Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	September 2, 2015
Completion date	December 28, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06033261` - A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes	Phase 1/Phase 2
Completed	`NCT00362297` - Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2	Phase 4
Completed	`NCT01132729` - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions	N/A
Completed	`NCT01132716` - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions	N/A
Terminated	`NCT01658826` - Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes	Phase 2
Completed	`NCT00262106` - Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection	Phase 3
Completed	`NCT01346475` - Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2	Phase 4
Completed	`NCT01390805` - Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)	N/A
Terminated	`NCT03146403` - Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection	Phase 2
Completed	`NCT03080961` - The VIBLOK SAfety and perFormancE Trial	N/A
Completed	`NCT00306787` - Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes	Phase 3
Completed	`NCT00231049` - Trial Evaluating Safety, Tolerability and Immune Response of AG-707	Phase 1
Completed	`NCT00477334` - Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients	Phase 4
Completed	`NCT00495573` - HSV-2 Shedding Resolution After Acyclovir Treatment	N/A
Not yet recruiting	`NCT03595995` - A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621	Phase 2
Completed	`NCT01281007` - Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes	Phase 3
Completed	`NCT01112956` - Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2	N/A
Completed	`NCT00129818` - A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding	Phase 4
Completed	`NCT00808405` - GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women	N/A
Terminated	`NCT00495716` - Effect of HSV-2 Suppressive Therapy on Sexual Behavior	Phase 4