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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone combination in relieving the symptoms associated with Climacteric Syndrome.

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

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.

Conditions
-----------------
Climacteric Syndrome

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Active drug


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients enrolled in this arm will take a tablet twice a day | Drug: Placebo<br> <br> |
| Active Comparator: Passiflora incarnata and isoflavona combination<br>Patients enrolled in this arm will take a tablet twice a day | Drug: Active drug<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopause Rating Scale - MRS |  | 104 days | 

Secondary Outcome Measures

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