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

October 18, 2016 updated by: Ache Laboratorios Farmaceuticos S.A.

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.

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04062-003
        • ISBEM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Menopause Rating Scale - MRS
Time Frame: 104 days
104 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Kuppperman-Blatt index
Time Frame: 90 days
90 days
MRS scale
Time Frame: 90 days
90 days
MENQOL
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (ESTIMATE)

September 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ACH-SNT-03(01/12)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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