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

NCT01805674 | Completed

• 1 other identifier: ESTROCALVI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Menopause

Keywords

menopause; quality of life; soy isoflavones; magnolia extract

Outcome Measures

Primary Outcomes (1)

• the quality of life measured by the scale of Cervantes

  The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women

  baseline and 12 weeks

Secondary Outcomes (1)

• Clinical changes in vasomotor symptomatology

  baseline, 2, 4, 8 and 12 weeks

Study Arms (1)

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.

Dietary Supplement: isoflavones combined with magnolia

Interventions

isoflavones combined with magnolia DIETARY_SUPPLEMENT

1 tablet/day duration: 12 weeks

Also known as: Estromineral Serena

isoflavones combined with magnolia

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in patients with typical mild to mderate vasomotor symptoms and psycho symptoms such as mood changes, or sleep, anxiety / depression, which do not require specific drug treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rottapharm Spain: lead

Study Sites (10)

Somdex S.L.

Barcelona, Barcelona, 08017, Spain

Location

Centro Médico Teknon

Barcelona, Barcelona, 08022, Spain

Location

Surgery of Dr. Sánchez Muñoz

Ciudad Real, Ciudad Real, 13004, Spain

Location

Gabinete Médico Velazquez

Madrid, Madrid, 28001, Spain

Location

Clínica ginecológica Cecchini

Oviedo, Oviedo, 33004, Spain

Location

Instituto Sevillano de Ginecología y Obstetricia

Seville, Sevilla, 41003, Spain

Location

Surgery of Dr. Mahiques

Valencia, Valencia, 46006, Spain

Location

Surgery of Dr. Raga

Valencia, Valencia, 46006, Spain

Location

Grupo hospitalario Quirón

Erandio, Vizcaya, 48950, Spain

Location

Centro Ginecológico Dr. García Pérez-Llantada SL

Zaragoza, Zaragoza, 50008, Spain

Location

Study Officials

• Anna Anguera, MD, PhD

  Rottapharm S.L.

  STUDY DIRECTOR

• Rafael Sánchez-Borrego, MD

  Centro Médico Teknon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 6, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 5, 2014

Record last verified: 2014-11

Locations

ES (10)