GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms (657/10UFCSPA)
This study is not yet open for participant recruitment.
Verified December 2011 by Phytopharm Consulting Brazil
Sponsor:
Phytopharm Consulting Brazil
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
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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:
|
|
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:
|
|
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
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 Uterine Hemorrhage Pathologic Processes |
Menstruation Disturbances Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013