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GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

NCT01365676 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2011-12-06

No results posted yet for this study

Summary

2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as antidepressant will be prescribed together for treating women with Premenstrual Syndrome (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE® prescription alone.

Conditions

  • Premenstrual Syndrome
  • Uterus; Hemorrhage, Preclimacteric or Premenopausal

Interventions

DRUG

GAMALINE® + HIPERICIN®

GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)

DRUG

GAMALINE®

GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)

Sponsors & Collaborators

  • Herbarium Laboratorio Botanico Ltda

    collaborator INDUSTRY

  • Federal University of Health Science of Porto Alegre

    collaborator OTHER

  • Phytopharm Consulting Brazil

    lead NETWORK

Principal Investigators

  • Carla Vanin, MD MSc PhD · UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre

  • Karla F Deud José, PharmD PhD · Phytopharm Consulting Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01365676 on ClinicalTrials.gov