GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

Premenstrual Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01365676
• Other study ID #: GAM+HIP
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 26, 2011
• Last updated: December 5, 2011
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2011
• Source: Phytopharm Consulting Brazil
• Contact: Marli Chaves, Secretary
• Phone: +55 51 8130-8454
• Email: tpm[@]phytopharm.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Uterine Hemorrhage
• Uterus; Hemorrhage, Preclimacteric or Premenopausal

Intervention

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)
• GAMALINE®
GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)

Locations

Country	Name	City	State
Brazil	Ambulatório de Ginecologia e Obstetrícia ISCMPA	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Phytopharm Consulting Brazil	Federal University of Health Science of Porto Alegre, Herbarium Laboratório Botânico Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	No