Phytoserms for Menopause Symptoms and Age-Associated Memory Decline (phytoSERM)

University of Southern California

Status: Completed

Conditions: Hot Flashes; Memory Loss

Treatments: Dietary Supplement: placebo; Dietary Supplement: PhytoSERM tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01723917

AG033288

R01AG033288 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.

Enrollment: 71 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-menopausal women
• ages 45 - 60 (inclusive)
• must have a vasomotor symptom (e.g., hot flash) and a memory complaint

Exclusion criteria

• history of clinically significant stroke
• current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
• Known allergy to soy derived products; hypersensitivity to estrogens or progestins

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 3 patient groups, including a placebo group

PhytoSERM 50 mg tablet

Experimental group

Description:

Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks

Treatment:

Dietary Supplement: PhytoSERM tablet

PhytoSERM 100 mg tablet

Experimental group

Description:

Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks

Treatment:

Dietary Supplement: PhytoSERM tablet

Placebo tablet

Placebo Comparator group

Description:

Dietary supplement: placebo tablet to be taken once per day for 12 weeks

Treatment:

Dietary Supplement: placebo