Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women

Completed

• Conditions: Menopause
• Interventions: Dietary Supplement: isoflavones combined with magnolia

• Registration Number: NCT01805674
• Lead Sponsor: Rottapharm Spain

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 adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.

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 symptoms and psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require specific drug treatment.

Quality of life will be analyzed by the scale of Cervantes.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
isoflavones combined with magnolia	isoflavones combined with magnolia	A food supplement containing soy isoflavones, lactobacillus sporogenous, Ca,vitamin D3, magnesium and magnolia extract will be administered once a day during 12 weeks.

Primary Outcome Measures

Name	Time	Method
the quality of life measured by the scale of Cervantes	baseline and 12 weeks	The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women

Secondary Outcome Measures

Name	Time	Method
Clinical changes in vasomotor symptomatology	baseline, 2, 4, 8 and 12 weeks	In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit

Trial Locations

Locations (10)

Surgery of Dr. Sánchez Muñoz; 🇪🇸 Ciudad Real, Spain

Clínica ginecológica Cecchini; 🇪🇸 Oviedo, Spain

Centro Médico Teknon; 🇪🇸 Barcelona, Spain

Grupo hospitalario Quirón; 🇪🇸 Erandio, Vizcaya, Spain

Surgery of Dr. Raga; 🇪🇸 Valencia, Spain

Instituto Sevillano de Ginecología y Obstetricia; 🇪🇸 Sevilla, Spain

Somdex S.L.; 🇪🇸 Barcelona, Spain

Surgery of Dr. Mahiques; 🇪🇸 Valencia, Spain

Gabinete Médico Velazquez; 🇪🇸 Madrid, Spain

Centro Ginecológico Dr. García Pérez-Llantada SL; 🇪🇸 Zaragoza, Spain