Trial record 3 of 22 for:    monalisa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695616
Recruitment Status : Withdrawn
First Posted : September 28, 2012
Last Update Posted : October 19, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Climacteric Syndrome Drug: Placebo Drug: Active drug Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Passiflora

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients enrolled in this arm will take a tablet twice a day
Drug: Placebo
Active Comparator: Passiflora incarnata and isoflavona combination
Patients enrolled in this arm will take a tablet twice a day
Drug: Active drug

Primary Outcome Measures :
  1. Menopause Rating Scale - MRS [ Time Frame: 104 days ]

Secondary Outcome Measures :
  1. Kuppperman-Blatt index [ Time Frame: 90 days ]
  2. MRS scale [ Time Frame: 90 days ]
  3. MENQOL [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695616

São Paulo, Brazil, 04062-003
Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.

Responsible Party: Ache Laboratorios Farmaceuticos S.A. Identifier: NCT01695616     History of Changes
Other Study ID Numbers: ACH-SNT-03(01/12)
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016