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

Phase 3

Withdrawn

• Conditions: Climacteric Syndrome
• Interventions: Drug: Active drug; Drug: Placebo

• Registration Number: NCT01695616
• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.

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

Study Timeline

• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passiflora incarnata and isoflavona combination	Active drug	Patients enrolled in this arm will take a tablet twice a day
Placebo	Placebo	Patients enrolled in this arm will take a tablet twice a day

Primary Outcome Measures

Name	Time	Method
Menopause Rating Scale - MRS	104 days

Secondary Outcome Measures

Name	Time	Method
Kuppperman-Blatt index	90 days
MRS scale	90 days
MENQOL	90 days

Trial Locations

Locations (1)

ISBEM; 🇧🇷 São Paulo, Brazil