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 range

25 Years – 55 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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