NCT01283568

Brief Summary

GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant extracts. The investigators will try the mixture and see if the vasomotor symptoms will disappear. The investigators expect that together all symptoms will be covered better than Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting point, 30 days and 180 days).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

January 24, 2011

Last Update Submit

November 25, 2011

Conditions

EdemaDepressionHot FlashesAnxietyIrritability

Keywords

PMS, climacteric, depression

Study Arms (4)

1 - Gamaline+Hipericin - fertile women

2- Gamaline+Hipericin - climateric women

3- Gamaline- control - fertile women

4 - Gamaline control - climateric women

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Only women from 25 to 55 years old with PMS symptoms

You may qualify if:

  • climacteric pre-menopausal women between 45 e 55 anos
  • women between 25 e 44 anos

You may not qualify if:

  • Age inferior 25 anos or superior 55 anos and/or decline invitation.
  • Patients pos-menopause
  • Under hormone therapy
  • Thyroid disease
  • Under psychiatric therapy or medication
  • History for allergies and hypersensitivity to one or both extracts
  • Breast feeding or pregnancy
  • No knowledge for writing and/or reading

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatório de Ginecologia e Obstetrícia ISCMPA

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

MeSH Terms

Conditions

EdemaDepressionHot FlashesAnxiety Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Karla F Deud José, Pharm PhD

    Phytopharm Consulting Brazil - karla@phytopharm.com.br

    STUDY CHAIR

Central Study Contacts

Carla Vanin, MD MSc PhD

CONTACT

+55 51 99628061carlavanin@terra.com.br

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 26, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

BR(1)