Efficacy and Safety of Passiflora Incarnata and Isoflavona Combination in the Treatment of Climacteric Symptoms (Monalisa)

This study is not yet open for participant recruitment.

Verified September 2012 by Ache Laboratorios Farmaceuticos S.A.

Sponsor:

Information provided by (Responsible Party):

Ache Laboratorios Farmaceuticos S.A.

ClinicalTrials.gov Identifier:

NCT01695616

First received: September 26, 2012

Last updated: September 27, 2012

Last verified: September 2012

History of Changes

Purpose

The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone combination in relieving the symptoms associated with Climacteric Syndrome.

Condition	Intervention	Phase
Climacteric Syndrome	Drug: Placebo Drug: Active drug	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Passiflora Incarnata and Isoflavona Combination in the Treatment of Climacteric Symptoms.

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Passiflora

U.S. FDA Resources

Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:

Menopause Rating Scale - MRS [ Time Frame: 104 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Kuppperman-Blatt index [ Time Frame: 90 days ] [ Designated as safety issue: No ]
MRS scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
MENQOL [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	144
Study Start Date:	August 2013
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Patients enrolled in this arm will take a tablet twice a day	Drug: Placebo
Active Comparator: Passiflora incarnata and isoflavona combination Patients enrolled in this arm will take a tablet twice a day	Drug: Active drug

Detailed Description:

It is known that Hormone Therapy is recommended postmenopausal women to reduce menopausal symptoms and prevent osteoporosis frames and cardiovascular disease. However, only 30 to 40% of women still using hormone therapy.

One reason women do not continue or are reluctant to start Hormone Therapy is realizing that the prescription of hormones is not a natural situation. Therefore, there is an increased interest in the use and prescription of estrogen derived from plants, known as fitoestrogênios.

The development of a drug containing two standardized extracts was focused on two main symptoms of menopause: hot flashes and anxiety. This product comes from a longing for the doctors themselves can respond more promptly to patients who reach menopause and who already has a framework for mild to moderate anxiety.

Thus, to meet the woman who develops menopausal symptoms and that these two are highly prevalent during menopause, causing intense discomfort routine for this woman, was produced in association with Soy Passiflora aiming to control anxiety and hot flushes

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female amenorrheic for at least one (1) year or surgical menopause since dosage of FSH ≥ 30 mIU / ml;
Age greater than or equal to 40 and less than or equal to 65 years;
Cytological examination colpo held at screening visit, Pap cytology classification with class I and II;
By mammography BI-RADS classification (fourth edition) rated one (1) or two (2) performed at least six (6) months from the time of inclusion in the screening visit or if the research subject does not present a recent survey ;
Line endometrial ≤ 8 mm by transvaginal ultrasound, performed at screening visit, in the case of subjects who have an intact uterus;

Exclusion Criteria:

History of severe liver or renal disease at the discretion of the investigator;
Hypertension stage III uncontrolled (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg);
Important cardiovascular disease such as coronary insufficiency or dilated cardiomyopathy advanced;
Using estrogens, progestins, steroid or hormone replacement therapy (HRT) in the last 3 months;
Estrogen-dependent neoplasia;
Thromboembolic disorders for less than one year of screening visit;
Anabolic drugs use or illicit drug use;
Hemoglobin < 10 or > 17 g / dL;
TSH < 0, 550 or > 4, 780 UUI / L;
FT4 < 0.75 ηg / dL or > 1.8 ηg / dL;
Patient that is chronically using MAO inhibitors (MAOIs) or levothyroxine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695616

Contacts

Contact: Monica Mathias, Doctor

+55 11 99996 6482

monica.mathias@ache.com.br

Locations

Brazil
ISBEM	Not yet recruiting
São Paulo, Brazil, 04062-003
Contact: César Eduardo Fernandes, Doctor +55 11 5583 1511 pesquisa@isbem.com.br
Contact: Eloisiei Garbugio +55 11 5583 1511 elo@isbem.com.br
Principal Investigator: César Fernandes, Doctor
Principal Investigator: Regina Ares, Doctor
Principal Investigator: Sonia Yurico Omori Del Debbio, Doctor
Principal Investigator: Renata Alexandra Calixto Pinheiro, Doctor

Sponsors and Collaborators

Ache Laboratorios Farmaceuticos S.A.

More Information

No publications provided

Responsible Party:	Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:	NCT01695616 History of Changes
Other Study ID Numbers:	ACH-SNT-03(01/12)
Study First Received:	September 26, 2012
Last Updated:	September 27, 2012
Health Authority:	Brazil: Ethics Committee Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 22, 2013

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