Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Melatonin Effects on Genital Herpes in Brazilian Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831165
Recruitment Status : Unknown
Verified July 2018 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE July 3, 2018
First Posted Date  ICMJE February 5, 2019
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE September 2, 2015
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
Recrutining pacients [ Time Frame: 1 year ]
Patients will be recruited in the Clinic, Department of Gynecology, Hospital das Clinicas, Faculty of Medicine, University of São Paulo
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melatonin Effects on Genital Herpes in Brazilian Women
Official Title  ICMJE Effects of Melatonin in the Treatment of Genital Herpes
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. Outcame 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 intumor cells .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
Masking Description:
The patients will be treated at the Clinic of Gynecology, USP 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 CD4 +, interleukin-2 and serology for herpes.
Primary Purpose: Treatment
Condition  ICMJE Genital Herpes
Intervention  ICMJE
  • Combination Product: Melatonin
    The volunteers will receive information about the study and sign the free and informed consent form (ICF). After, will be delivered bottle identified by letters (abc, bca or cab) with its drug without patient and investigator know its nature. It will only be revealed which drug was used by every woman at the end of the study; but occurring worsening of herpetic disease, the blind will be broken for proper assessment of the participant. If the employee drug is melatonin, this case will be considered as therapeutic failure in the final statistical analysis.
    Other Name: placebo
  • Drug: Acyclovir 400 MG
    These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days
Study Arms  ICMJE
  • Experimental: melatonin 3mg + Acyclovir 400mg
    GI - melatonin 3mg + Acyclovir 400mg
    Interventions:
    • Combination Product: Melatonin
    • Drug: Acyclovir 400 MG
  • Active Comparator: Acyclovir 400mg
    GII - Acyclovir 400mg twice a day
    Interventions:
    • Combination Product: Melatonin
    • Drug: Acyclovir 400 MG
  • Placebo Comparator: placebo + melatonin 3mg
    GIII - placebo + melatonin 3mg
    Interventions:
    • Combination Product: Melatonin
    • Drug: Acyclovir 400 MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 1, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • clinical and laboratory diagnosis of genital herpes
  • real time PCR
  • serology

Exclusion criteria:

  • immunodeficiencies
  • pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female only
Ages  ICMJE 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03831165
Other Study ID Numbers  ICMJE 1215208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edmund C Baracat, PhD Universidade de Sao Paulo General Hospital
PRS Account University of Sao Paulo General Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP