Postmenopausal Women With Moderate Vasomotor Symptoms Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Tolerability of the Combination of Soy Isoflavones and Red Clover Extract (FITOGYN) in the Treatment of the Hot Flushes in Menopausal Women.
The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate the quality of life associated to the vasomotor symptoms of menopause.
One of the most significant problems for assessing treatment of hot flushes is the placebo
effect. A Phase IV study with an innovative design, intended to additionally assess such
effect, is reported. The efficacy of Fitogyn for the treatment of hot flushes in menopausal
women with moderate symptoms will be assessed. Secondary objectives will include evaluation
of the impact of Fitogyn as compared to placebo on overall menopause symptoms (fatigue,
joint pain, vaginal dryness, and sleep disturbances), anxiety, quality of life, and
cardiovascular parameters. Equol levels in blood will also be measured to study its
potential impact on the outcome of treatment with these isoflavones.
The duration of the study participants will be 22 weeks. 7 visits are planned during the
study:
After the screening visit (visit 1), women selected will report on the daily occurrence of
hot flushes for 2 weeks without treatment. If they experience the required number of hot
flushes (35-70 hot flushes in the prior week and 9 or more of them with at least moderate
intensity), a 4-week placebo run-in period will start (visit 2). After this time (Visit 3),
women with a decrease lower than 25% in the number of hot flushes and a treatment adherence
of at least 80% will be randomised to receive treatment (Fitogyn vs placebo) for 16 weeks.
During visit 3, baseline assessments of primary and secondary variables will be carried out.
Additionally, blood and urine samples will be obtained to conduct hematological and
biochemical tests, and assess thyroid function and lipid profile. In addition, patients will
complete the following scales: "Menopausal Rating Scale (MRS)", the scales of anxiety (HADS)
and quality of life (Scale of Cervantes).
Visits 4, 5 and 6: To assess every 4 weeks the treatment adherence, to do a safety
evaluation and daily collection of hot flashes.
Visit 7: End of study (week 22 of study). During this visit the same activities described
for visit 3 will be performed.
SUBSTUDY:
TITLE: "Evaluating the impact of the combination of soy isoflavones and red clover extract
(FITOGYN) compared to placebo on some markers of atherogenesis"
The substudy will be conducted in a subsample of approximately 90 patients and will involve
those Investigational Sites willing to conduct the substudy, given that they have the means
for the proper and correct handling of samples. This study has an exploratory purpose, and
will provide useful insight into the specific mechanisms of action of phytoestrogens as well
as generate new hypotheses that can guide future research on this product. Additionally,
blood equol levels will be measured to study their potential effect on treatment outcome
with these isoflavones.
A number of biological parameters have been identified that are clearly related to the
process of atherogenesis. This measurement would be from blood collections performed at
baseline and the end of the trial, so that new blood collections will not be necessary
beyond those already planned.
The selected parameters are:
1. Level of insulin resistance from HOMA.
2. Low density lipoprotein (LDL), oxidized (ox LDL) concentration.
3. Asymmetric dimethyl arginine concentration in endothelial cell culture
4. Measure the ratio of prostacyclin / thromboxane in urine.
5. Genesis of tissue factor in the endothelium.
6. Measurement of blood levels of equol.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment