GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms
657/10UFCSPA
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
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 6, 2011
December 1, 2011
7 months
May 26, 2011
December 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
240 days
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)
T0 T1 and T6
Secondary Outcomes (1)
WHOQOL
06 months
Study Arms (4)
GAMALINE® + HIPERICIN® 25-44 years old
EXPERIMENTALFertile women 24-44 years old with PMS symptoms
GAMALINE® 25-44 years old
ACTIVE COMPARATORFertile women 24-44 years old with PMS symptoms
GAMALINE® + HIPERICIN® 45-55 years old
EXPERIMENTALClimacteric women with PMS symptoms
GAMALINE® 45-55 years old
ACTIVE COMPARATORClimacteric women with PMS symptoms
Interventions
GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)
GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)
Eligibility Criteria
You may qualify if:
- fertile women between 25-44 years old
- climacteric women between 45-55 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambulatório de Ginecologia e Obstetrícia ISCMPA
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2011
First Posted
June 3, 2011
Study Start
March 1, 2012
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
December 6, 2011
Record last verified: 2011-12