Isoflavones and Magnolia Extract in the Quality of Life i... | NCT01805674

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

NCT01805674

Sponsor

Rottapharm Spain

Status

Completed

Last Update Posted

Nov 5, 2014Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Menopause

Interventions

isoflavones combined with magnolia

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jul 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Mar 1, 2013

First Submission Date that Met QC Criteria

Mar 5, 2013

First Posted Date

Mar 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2014

Last Update Posted Date

Nov 5, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
isoflavones combined with magnolia	Dietary Supplement	1 tablet/day duration: 12 weeks	isoflavones combined with magnolia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

59 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Anguera, MD, PhD	Rottapharm S.L.	Study Director
Rafael Sánchez-Borrego, MD	Centro Médico Teknon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Somdex S.L.		Barcelona	Barcelona	08017	Spain
Centro Médico Teknon