Back to resultsGAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms (657/10UFCSPA)
Primary Purpose
Premenstrual Syndrome, Uterus; Hemorrhage, Preclimacteric or Premenopausal
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
GAMALINE® + HIPERICIN®
GAMALINE®
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Edema, Depression, Hot Flashes, Anxiety, Irritability, PMS
Eligibility 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
Sites / Locations
- Ambulatório de Ginecologia e Obstetrícia ISCMPA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
GAMALINE® + HIPERICIN® 25-44 years old
GAMALINE® 25-44 years old
GAMALINE® + HIPERICIN® 45-55 years old
GAMALINE® 45-55 years old
Arm Description
Fertile women 24-44 years old with PMS symptoms
Fertile women 24-44 years old with PMS symptoms
Climacteric women with PMS symptoms
Climacteric women with PMS symptoms
Outcomes
Primary Outcome Measures
PMS calendar
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
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
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.
Full Information
NCT ID
NCT01365676
First Posted
May 26, 2011
Last Updated
December 5, 2011
Sponsor
Phytopharm Consulting Brazil
Collaborators
Herbarium Laboratorio Botanico Ltda, Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01365676
Brief Title
GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms
Acronym
657/10UFCSPA
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phytopharm Consulting Brazil
Collaborators
Herbarium Laboratorio Botanico Ltda, Federal University of Health Science of Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Uterus; Hemorrhage, Preclimacteric or Premenopausal
Keywords
Edema, Depression, Hot Flashes, Anxiety, Irritability, PMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GAMALINE® + HIPERICIN® 25-44 years old
Arm Type
Experimental
Arm Description
Fertile women 24-44 years old with PMS symptoms
Arm Title
GAMALINE® 25-44 years old
Arm Type
Active Comparator
Arm Description
Fertile women 24-44 years old with PMS symptoms
Arm Title
GAMALINE® + HIPERICIN® 45-55 years old
Arm Type
Experimental
Arm Description
Climacteric women with PMS symptoms
Arm Title
GAMALINE® 45-55 years old
Arm Type
Active Comparator
Arm Description
Climacteric women with PMS symptoms
Intervention Type
Drug
Intervention Name(s)
GAMALINE® + HIPERICIN®
Other Intervention Name(s)
GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9, HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0
Intervention Description
GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)
Intervention Type
Drug
Intervention Name(s)
GAMALINE®
Other Intervention Name(s)
GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9
Intervention Description
GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)
Primary Outcome Measure Information:
Title
PMS calendar
Description
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).
Time Frame
240 days
Title
LAB Tests
Description
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)
Time Frame
T0 T1 and T6
Secondary Outcome Measure Information:
Title
WHOQOL
Description
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.
Time Frame
06 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marli Chaves, Secretary
Phone
+55 51 8130-8454
Email
tpm@phytopharm.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo Remus, Physical Education
Phone
+55 51 9191-6535
Email
remus@phytopharm.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Vanin, MD MSc PhD
Organizational Affiliation
UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karla F Deud José, PharmD PhD
Organizational Affiliation
Phytopharm Consulting Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
Ambulatório de Ginecologia e Obstetrícia ISCMPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marli Chaves
Phone
+55 51 81308454
Email
tpm@phytopharm.com.br
First Name & Middle Initial & Last Name & Degree
Karla F Deud José, PharmD PhD
Phone
+55 51 92793075
Email
karla@phytopharm.com.br
First Name & Middle Initial & Last Name & Degree
Carla Vanin, MD MSc PhD
First Name & Middle Initial & Last Name & Degree
Raquel P Dibi, MD MSc
12. IPD Sharing Statement
Learn more about this trial
GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms
We'll reach out to this number within 24 hrs