Premenstrual SyndromePhase 3657/10UFCSPANCT01365676
GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms
A Phase 3 study testing GAMALINE® + HIPERICIN® and GAMALINE® in people with Premenstrual Syndrome and Uterus; Hemorrhage, Preclimacteric or Premenopausal, run by Phytopharm Consulting Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Uterus; Hemorrhage, Preclimacteric or Premenopausal
- What is being tested?
- GAMALINE® + HIPERICIN® and GAMALINE®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- fertile women between 25-44 years old
- climacteric women between 45-55 years old
Who cannot join
- inferior age to 25 years old
- superior age to 55 years old
- post-menopausal
- under hormone therapy
- thyroid disease
- under psychiatric therapy or medication
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- history for allergies and/or hypersensitivity to any component
- breast feeding or pregnancy
- no knowledge for writing and/or reading
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ambulatório de Ginecologia e Obstetrícia ISCMPA
Porto Alegre, Rio Grande do Sul, 90020-090
Marli Chaves, +55 51 81308454, tpm@phytopharm.com.br
Karla F Deud José, PharmD PhD, +55 51 92793075, karla@phytopharm.com.br
About this study
Official title: Phase 3 Study Efficacy and Tolerance: The Use of 2 Phytomedicines in Association GAMALINE® 900mg + HIPERICIN® 300mg for the Treatment of Pre-Menstrual Syndrome (PMS) and Vasomotor Symptoms
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.
Read the detailed 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.
- Being tested
- GAMALINE® + HIPERICIN®, GAMALINE®
- Keywords
- Edema, Depression, Hot Flashes, Anxiety, Irritability, PMS
- Medical subject headings
- Premenstrual Syndrome, Hemorrhage, Edema, Depression, Hot Flashes, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAMALINE® + HIPERICIN®Drug
Also called GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9, HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0
GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)
GAMALINE®Drug
Also called GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9
GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)
| Study group | Role | What they receive |
|---|---|---|
| GAMALINE® + HIPERICIN® 25-44 years old | Experimental | Fertile women 24-44 years old with PMS symptoms Receives: Drug: GAMALINE® + HIPERICIN® |
| GAMALINE® 25-44 years old | Active comparator | Fertile women 24-44 years old with PMS symptoms Receives: Drug: GAMALINE® |
| GAMALINE® + HIPERICIN® 45-55 years old | Experimental | Climacteric women with PMS symptoms Receives: Drug: GAMALINE® + HIPERICIN® |
| GAMALINE® 45-55 years old | Active comparator | Climacteric women with PMS symptoms Receives: Drug: GAMALINE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
PMS calendar
Evaluation will run daily during the 240 days, comparing the results before treatment [60 days (T-2) and 30 days (T-1)]. Starting point (T0) treatment/under prescription, till 180 days treatment (T6).
Measured: 240 days
LAB Tests
Blood sample tests before T0 (all arms), after T1 (30 days only for experimental group) and end of T6 (after 180 days of prescription for all arms)
Measured: T0 T1 and T6
Secondary outcomes (1)
WHOQOL
WHOQOL will be evaluated at T-2 and T6 where T-2 is at the first interview after inclusion and T6 is at the end point of treatment.
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phytopharm Consulting Brazil
- Sponsor type
- Research network
- Collaborators
- Herbarium Laboratorio Botanico Ltda, Federal University of Health Science of Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Carla Vanin, MD MSc PhD, Principal investigator, UFCSPA-Universidade Federal de Ciências da Saúde de Porto AlegreKarla F Deud José, PharmD PhD, Study chair, Phytopharm Consulting Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365676
- Sponsor's protocol ID
- GAM+HIP
- Acronym
- 657/10UFCSPA
- Status last verified
- Dec 2011
- First submitted
- 26 May 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Efficacy and Tolerance: The Use of 2 Phytomedicines in Association GAMALINE® 900mg + HIPERICIN® 300mg for the Treatment of Pre-Menstrual Syndrome (PMS) and Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT01365676
- Acronym / sponsor ID
- 657/10UFCSPA / GAM+HIP
- Keywords
- Edema, Depression, Hot Flashes, Anxiety, Irritability, PMS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Phytopharm Consulting BrazilResearch network
- Collaborators
- Herbarium Laboratorio Botanico Ltda, Federal University of Health Science of Porto Alegre
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GAMALINE® + HIPERICIN® 25-44 years old | Experimental | Drug: GAMALINE® + HIPERICIN®Fertile women 24-44 years old with PMS symptoms |
| GAMALINE® 25-44 years old | Active comparator | Drug: GAMALINE®Fertile women 24-44 years old with PMS symptoms |
| GAMALINE® + HIPERICIN® 45-55 years old | Experimental | Drug: GAMALINE® + HIPERICIN®Climacteric women with PMS symptoms |
| GAMALINE® 45-55 years old | Active comparator | Drug: GAMALINE®Climacteric women with PMS symptoms |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- fertile women between 25-44 years old
- climacteric women between 45-55 years old
Key exclusion criteria (9 listed)
- inferior age to 25 years old
- superior age to 55 years old
- post-menopausal
- under hormone therapy
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAMALINE® + HIPERICIN®Also: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9, HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month) | Drug | GAMALINE® + HIPERICIN® 25-44 years old, GAMALINE® + HIPERICIN® 45-55 years old |
| GAMALINE®Also: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month) | Drug | GAMALINE® 25-44 years old, GAMALINE® 45-55 years old |
Primary outcome
PMS calendar
Time frame: 240 days
Evaluation will run daily during the 240 days, comparing the results before treatment [60 days (T-2) and 30 days (T-1)]. Starting point (T0) treatment/under prescription, till 180 days treatment (T6).
LAB Tests
Time frame: T0 T1 and T6
Blood sample tests before T0 (all arms), after T1 (30 days only for experimental group) and end of T6 (after 180 days of prescription for all arms)
1 secondary outcome
WHOQOL
Time frame: 06 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Vanin, MD MSc PhD principal investigator
UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre
Karla F Deud José, PharmD PhD study chair
Phytopharm Consulting Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GAMALINE® + HIPERICIN® and GAMALINE® in people with Premenstrual Syndrome and Uterus; Hemorrhage, Preclimacteric or Premenopausal, run by Phytopharm Consulting Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marli Chaves, Secretary (+55 51 8130-8454, tpm@phytopharm.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PMS calendar (time frame: 240 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.