Status:
COMPLETED
Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women
Lead Sponsor:
Rottapharm Spain
Conditions:
Menopause
Eligibility:
FEMALE
45-59 years
Brief Summary
In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life. The improvement of the quality could be reached with...
Detailed Description
Multicenter, observational, prospective, longitudinal study of clinical practice conducted in 10 gynecological centers. The study will be conducted in patients with typical mild to moderate vasomotor...
Eligibility Criteria
Inclusion
- Women with at least 12 months of amenorrhea
- Presence of 1 or more vasomotor symptoms as hot flushing, nocturnal sweating or palpitations
- One or more psychological symptoms as insomnia, irritability, anxiety, depressed mood. Also with concomitant symptoms of sexual area as reduction of libido and vaginal dryness.
- Women must give the informed consent
Exclusion
- clinical history of medical or surgical pathologies that could affect the results of the study, including serious cardiovascular, metabolic, kidney or liver diseases
- Patients with the habit of eating soy foods or dietary supplements with soy extract
- patients diagnosed with breast or uterine mass (neoplasia hormone sensitive)
- patients that were treated with estrogens (HRT or phytoestrogens)in the 2 months before the beginning of the study.
- patients with treatment with antibiotics, antidepressant and/or anxiolytic products
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01805674
Start Date
March 1 2013
End Date
October 1 2013
Last Update
November 5 2014
Active Locations (10)
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1
Somdex S.L.
Barcelona, Barcelona, Spain, 08017
2
Centro Médico Teknon
Barcelona, Barcelona, Spain, 08022
3
Surgery of Dr. Sánchez Muñoz
Ciudad Real, Ciudad Real, Spain, 13004
4
Gabinete Médico Velazquez
Madrid, Madrid, Spain, 28001