GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms (657/10UFCSPA)

Phytopharm Consulting Brazil

Status and phase: Unknown; Phase 3

Conditions: Uterus; Hemorrhage, Preclimacteric or Premenopausal; Premenstrual Syndrome

Treatments: Drug: GAMALINE®; Drug: GAMALINE® + HIPERICIN®

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT01365676

GAM+HIP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups

GAMALINE® + HIPERICIN® 25-44 years old

Experimental group

Description:

Fertile women 24-44 years old with PMS symptoms

Treatment:

Drug: GAMALINE® + HIPERICIN®

GAMALINE® 25-44 years old

Active Comparator group

Description:

Fertile women 24-44 years old with PMS symptoms

Treatment:

Drug: GAMALINE®

GAMALINE® + HIPERICIN® 45-55 years old

Experimental group

Description:

Climacteric women with PMS symptoms

Treatment:

Drug: GAMALINE® + HIPERICIN®

GAMALINE® 45-55 years old

Active Comparator group

Description:

Climacteric women with PMS symptoms

Treatment:

Drug: GAMALINE®