GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

Phase 3

• Conditions: Premenstrual Syndrome; Uterus; Hemorrhage, Preclimacteric or Premenopausal
• Interventions: Drug: GAMALINE® + HIPERICIN®; Drug: GAMALINE®

• Registration Number: NCT01365676
• Lead Sponsor: Phytopharm Consulting Brazil

Brief 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.

Study Timeline

• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06
• Study Start: 2012-03
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GAMALINE® + HIPERICIN® 25-44 years old	GAMALINE® + HIPERICIN®	Fertile women 24-44 years old with PMS symptoms
GAMALINE® 25-44 years old	GAMALINE®	Fertile women 24-44 years old with PMS symptoms
GAMALINE® + HIPERICIN® 45-55 years old	GAMALINE® + HIPERICIN®	Climacteric women with PMS symptoms
GAMALINE® 45-55 years old	GAMALINE®	Climacteric women with PMS symptoms

Primary Outcome Measures

Name	Time	Method
PMS calendar	240 days	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	T0 T1 and T6	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

Name	Time	Method
WHOQOL	06 months	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.

Trial Locations

Locations (1)

Ambulatório de Ginecologia e Obstetrícia ISCMPA; 🇧🇷 Porto Alegre, RS, Brazil