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

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.

Study Overview

• Status: Unknown
• Conditions: Premenstrual Syndrome; Uterus; Hemorrhage, Preclimacteric or Premenopausal
• Intervention / Treatment: Drug: GAMALINE® + HIPERICIN®; Drug: GAMALINE®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marli Chaves, Secretary; Phone Number: +55 51 8130-8454; Email: tpm@phytopharm.com.br
• Study Contact Backup: Name: Gustavo Remus, Physical Education; Phone Number: +55 51 9191-6535; Email: remus@phytopharm.com.br

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Ambulatório de Ginecologia e Obstetrícia ISCMPA
      • Contact: Marli Chaves; Phone Number: +55 51 81308454; Email: tpm@phytopharm.com.br
      • Contact: Karla F Deud José, PharmD PhD; Phone Number: +55 51 92793075; Email: karla@phytopharm.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	06 months

Collaborators and Investigators

• Sponsor: Phytopharm Consulting Brazil
• Collaborators: Federal University of Health Science of Porto Alegre; Herbarium Laboratorio Botanico Ltda
• 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (ESTIMATE): June 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Edema; Irritability; PMS; Hot Flashes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Hemorrhage; Premenstrual Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Psychotropic Drugs; Antidepressive Agents; Hypericin
• Other Study ID Numbers: GAM+HIP