UnknownPhase 3

GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

Brazil240 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range25 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PMS calendar

Timeframe: 240 days

LAB Tests

Timeframe: T0 T1 and T6

Trial details

NCT IDNCT01365676

SponsorPhytopharm Consulting Brazil

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2012-10

Contact for this trial

Marli Chaves, Secretary

+55 51 8130-8454 tpm@phytopharm.com.br

View on ClinicalTrials.gov More Premenstrual Syndrome trials