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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Uterine Hemorrhage
Disease
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Uterine Diseases

ClinicalTrials.gov processed this record on November 27, 2014