GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms (657/10UFCSPA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Phytopharm Consulting Brazil.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Herbarium Laboratório Botânico Ltda
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier:
NCT01365676
First received: May 26, 2011
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Premenstrual Syndrome
Uterus; Hemorrhage, Preclimacteric or Premenopausal
Drug: GAMALINE® + HIPERICIN®
Drug: GAMALINE®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Phase 3 Study Efficacy and Tolerance: The Use of 2 Phytomedicines in Association GAMALINE® 900mg + HIPERICIN® 300mg for the Treatment of Pre-Menstrual Syndrome (PMS) and Vasomotor Symptoms

Resource links provided by NLM:


Further study details as provided by Phytopharm Consulting Brazil:

Primary Outcome Measures:
  • PMS calendar [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Evaluation will run daily during the 240 days, comparing the results before treatment [60 days (T-2) and 30 days (T-1)]. Starting point (T0) treatment/under prescription, till 180 days treatment (T6).

  • LAB Tests [ Time Frame: T0 T1 and T6 ] [ Designated as safety issue: Yes ]
    Blood sample tests before T0 (all arms), after T1 (30 days only for experimental group) and end of T6 (after 180 days of prescription for all arms)


Secondary Outcome Measures:
  • WHOQOL [ Time Frame: 06 months ] [ Designated as safety issue: No ]
    WHOQOL will be evaluated at T-2 and T6 where T-2 is at the first interview after inclusion and T6 is at the end point of treatment.


Estimated Enrollment: 240
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GAMALINE® + HIPERICIN® 25-44 years old
Fertile women 24-44 years old with PMS symptoms
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)
Other Names:
  • GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9
  • HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0
Active Comparator: GAMALINE® 25-44 years old
Fertile women 24-44 years old with PMS symptoms
Drug: GAMALINE®
GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)
Other Name: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9
Experimental: GAMALINE® + HIPERICIN® 45-55 years old
Climacteric women with PMS symptoms
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)
Other Names:
  • GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9
  • HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0
Active Comparator: GAMALINE® 45-55 years old
Climacteric women with PMS symptoms
Drug: GAMALINE®
GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)
Other Name: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9

Detailed Description:

Test with 2 female groups: 25-44 years old (reproductive age) and 45-55 years old (climacteric premenopausal age) complaining about all symptoms related with premenstrual syndrome.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fertile women between 25-44 years old
  • climacteric women between 45-55 years old

Exclusion Criteria:

  • inferior age to 25 years old
  • superior age to 55 years old
  • post-menopausal
  • under hormone therapy
  • thyroid disease
  • under psychiatric therapy or medication
  • history for allergies and/or hypersensitivity to any component
  • breast feeding or pregnancy
  • no knowledge for writing and/or reading
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365676

Contacts
Contact: Marli Chaves, Secretary +55 51 8130-8454 tpm@phytopharm.com.br
Contact: Gustavo Remus, Physical Education +55 51 9191-6535 remus@phytopharm.com.br

Locations
Brazil
Ambulatório de Ginecologia e Obstetrícia ISCMPA Not yet recruiting
Porto Alegre, RS, Brazil, 90020-090
Contact: Marli Chaves    +55 51 81308454    tpm@phytopharm.com.br   
Contact: Karla F Deud José, PharmD PhD    +55 51 92793075    karla@phytopharm.com.br   
Principal Investigator: Carla Vanin, MD MSc PhD         
Sub-Investigator: Raquel P Dibi, MD MSc         
Sponsors and Collaborators
Phytopharm Consulting Brazil
Herbarium Laboratório Botânico Ltda
Federal University of Health Science of Porto Alegre
Investigators
Principal Investigator: Carla Vanin, MD MSc PhD UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre
Study Chair: Karla F Deud José, PharmD PhD Phytopharm Consulting Brazil
  More Information

No publications provided

Responsible Party: Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier: NCT01365676     History of Changes
Other Study ID Numbers: GAM+HIP
Study First Received: May 26, 2011
Last Updated: December 5, 2011
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Phytopharm Consulting Brazil:
Edema
Depression
Hot Flashes
Anxiety
Irritability
PMS

Additional relevant MeSH terms:
Hemorrhage
Premenstrual Syndrome
Uterine Hemorrhage
Pathologic Processes
Menstruation Disturbances
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 23, 2014