GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Premenstrual Syndrome, Uterus; Hemorrhage, Preclimacteric or Premenopausal

Intervention / Treatment
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* Drug: GAMALINE® + HIPERICIN®
* Drug: GAMALINE®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAMALINE® + HIPERICIN® 25-44 years old<br>Fertile women 24-44 years old with PMS symptoms | Drug: GAMALINE® + HIPERICIN®<br>* GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)<br>* Other names: HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0;|
| Active Comparator: GAMALINE® 25-44 years old<br>Fertile women 24-44 years old with PMS symptoms | Drug: GAMALINE®<br>* GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)<br>* Other names: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9;|
| Experimental: GAMALINE® + HIPERICIN® 45-55 years old<br>Climacteric women with PMS symptoms | Drug: GAMALINE® + HIPERICIN®<br>* GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)<br>* Other names: HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0;|
| Active Comparator: GAMALINE® 45-55 years old<br>Climacteric women with PMS symptoms | Drug: GAMALINE®<br>* GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)<br>* Other names: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Edema, Depression, Hot Flashes, Anxiety, Irritability, PMS