GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365676

Acronym

657/10UFCSPA

Enrollment

240

Registered

2011-06-03

Start date

2012-03-31

Completion date

2012-12-31

Last updated

2011-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Syndrome, Uterus; Hemorrhage, Preclimacteric or Premenopausal

Keywords

Edema, Depression, Hot Flashes, Anxiety, Irritability, PMS

Brief 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.

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.

Interventions

DRUGGAMALINE® + HIPERICIN®

GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)

DRUGGAMALINE®

GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PMS calendar	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	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)

Secondary

Measure	Time frame	Description
WHOQOL	06 months	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.

Countries

Brazil

Contacts

Primary ContactMarli Chaves, Secretary

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

Backup ContactGustavo Remus, Physical Education

remus@phytopharm.com.br+55 51 9191-6535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026