NCT01365676

GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Phytopharm Consulting Brazil · Network
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Premenstrual Syndrome
• Uterus; Hemorrhage, Preclimacteric or Premenopausal

Interventions

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

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-06-03
• Last updated: 2011-12-06

Locations

1 site across 1 country: Brazil