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

Climacteric Syndrome Clinical Trial

— Monalisa  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01695616
• Other study ID #: ACH-SNT-03(01/12)
• Status: Withdrawn
• Phase: Phase 3
• First received: September 26, 2012
• Last updated: October 18, 2016
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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 ?g / dL or > 1.8 ?g / dL;

• Patient that is chronically using MAO inhibitors (MAOIs) or levothyroxine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Climacteric Syndrome

Intervention

Drug:
• Placebo

• Active drug

Locations

Country	Name	City	State
Brazil	ISBEM	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopause Rating Scale - MRS		104 days	No
Secondary	Kuppperman-Blatt index		90 days	No
Secondary	MRS scale		90 days	No
Secondary	MENQOL		90 days	No