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

NCT ID: NCT01695616

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-03-31

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

Conditions

Climacteric Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Patients enrolled in this arm will take a tablet twice a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Passiflora incarnata and isoflavona combination

Patients enrolled in this arm will take a tablet twice a day

Group Type: ACTIVE_COMPARATOR

Active drug

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: DRUG

Active drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ISBEM

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ACH-SNT-03(01/12)

Identifier Type: -

Identifier Source: org_study_id