NCT01805674

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

Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Rottapharm Spain · Industry
• Sex: Female
• Age: 45 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	isoflavones combined with magnolia	1 tablet/day duration: 12 weeks

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-07-01
• Completion: 2013-10-01
• First posted: 2013-03-06
• Last updated: 2014-11-05

Locations

10 sites across 1 country: Spain