- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01695616
Efficacy and Safety of Passiflora Incarnata and Isoflavona Combination in the Treatment of Climacteric Symptoms (Monalisa)
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.
Study Overview
Status
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
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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São Paulo, Brazil, 04062-003
- ISBEM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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ACTIVE_COMPARATOR: Passiflora incarnata and isoflavona combination
Patients enrolled in this arm will take a tablet twice a day
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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