Clinical trial NCT01695616: Efficacy and Safety of Passiflora Incarnata and Isoflavona Combination in the Treatment of Climacteric Symptoms
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Climacteric Syndrome
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2012-09-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Menopause Rating Scale - MRS
timeFrame: 104 days
Secondary outcomes:
measure: Kuppperman-Blatt index
timeFrame: 90 days
measure: MRS scale
timeFrame: 90 days
measure: MENQOL
timeFrame: 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: ISBEM
Study officials:
References: