GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

Last updated: December 5, 2011
Sponsor: Phytopharm Consulting Brazil
Overall Status: Trial Status Unknown

Phase

3

Condition

Premenstrual Syndrome

Hemorrhage

Uterine Disorders

Treatment

N/A

Clinical Study ID

NCT01365676
GAM+HIP
  • Ages 25-55
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • fertile women between 25-44 years old

  • climacteric women between 45-55 years old

Exclusion

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

Total Participants: 240
Study Start date:
March 01, 2012
Estimated Completion Date:
December 31, 2012

Study 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.

Connect with a study center

  • Ambulatório de Ginecologia e Obstetrícia ISCMPA

    Porto Alegre, RS 90020-090
    Brazil

    Site Not Available

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