A Nutritional Supplement on Vasomotor Symptoms in Women

NCT04516304 | Completed DMC

• 1 other identifier: BIO-1811
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes that occur at night, can be particularly bothersome in women and contribute to disturbed sleep. These symptoms occur mainly during the 1-3 years prior to menopause (late perimenopause) and early menopause (\~4 years after menstruation ceases). Many women look to supplements for the management of menopausal symptoms. Soy isoflavones and their metabolites are one category of dietary supplements that have been extensively studied for the management of VMS. The most active soy isoflavone is S-equol, which is not found directly in soy, but rather is the metabolite that is produced by gut microflora from consumption of the soy isoflavone daidzein. However, only 20-30% of US women are actually able to produce S-equol from the consumption of daidzein. Equelle® is a currently available dietary supplement that has S-equol as its active component, which allows the delivery of the active soy isoflavone metabolite directly without dependence on the gut microflora metabolism. The intention of this study is to assess the effect of a product containing S-equol on the management of VMS in normally healthy women. Condition or disease: Vasomotor Symptoms Intervention/treatment: Dietary Supplement: S-equol Dietary Supplement: Placebo

Conditions

Menopause

Keywords

menopause

Outcome Measures

Primary Outcomes (1)

• Vasomotor symptoms

  Daily frequency of vasomotor symptoms, including hot flushes and night sweats

  [Time Frame: Change from baseline to Week 12]

Secondary Outcomes (23)

• Vasomotor symptom

  [Time Frame: Change from baseline to Weeks 4 and 8]

• Hot Flush

  [Time Frame: Change from baseline to Weeks 4, 8, and 12]

• Night Sweat

  [Time Frame: Change from baseline to Weeks 4, 8, and 12]

• Vasomotor symptom severity - number

  [Time Frame: Change from baseline to Weeks 4, 8, and 12]

• Vasomotor symptom severity - total score

  [Time Frame: Change from baseline to Weeks 4, 8, and 12]

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo; Dietary Supplement: S-equol

Experimental

EXPERIMENTAL

S-equol

Dietary Supplement: Placebo; Dietary Supplement: S-equol

Interventions

Placebo DIETARY_SUPPLEMENT

4 tablets/d (2 in the morning and 2 in the evening)

Experimental; Placebo

S-equol DIETARY_SUPPLEMENT

4 tablets/d (2 in the morning and 2 in the evening), providing 10 mg S-equol total a day Other Names: •Equelle®

Experimental; Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a perimenopausal or menopausal female experiencing specific menopausal-related VMS.
• Subject has a BMI of ≥18.5 to ≤38.0 kg/m2 at Visit 1 (week -3).
• At screening visit (Visit 1; week -3), subject reports to have 4 or more moderate to severe hot flushes/night sweats during 24 h prior to the visit. At Visit 3 (week -1), subject has ≥25 moderate to severe hot flushes/night sweats per week for one week between Visit 2 and 3 (weeks -2 and -1). At Visit 4 (week 0), subject has an average ≥28 moderate to severe hot flushes/night sweats per week for 2 weeks before Visit 4 (week 0).
• Subject is willing to maintain habitual diet (with the exception of restricted foods/beverages), physical activity patterns, and body weight during the study period.
• Subject is willing to abstain from using products (other than study product) that contains estrogen, progestin, or progesterone within 30 d prior to Visit 1 (week -3) and throughout the study trial.
• If a smoker, subject is willing to maintain current smoking habits.
• Subject has no health conditions that would prevent her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

You may not qualify if:

• Subject has abnormal laboratory test results of clinical importance at Visit 1 (week -3) at the discretion of the Investigator.
• Subject has a history or presence of clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions), neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders, that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
• Subject has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
• Subject has a history of estrogen-dependent neoplasia, atypical ductual hyperplasia of the breast, or undiagnosed vaginal bleeding.
• Subject has a history of endometrial hyperplasia, melanoma, or uterine/endometrial breast or ovarian cancer.
• Subject has uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (week -3). One re-test will be allowed on a separate day for subjects whose blood pressure exceeds either of these cut points at Visit 1, in the judgment of the Clinical Investigator.
• Subject has a history of any major trauma or major surgical event within two months of Visit 1 (week -3).
• Subject has a history or presence of cancer in the prior 2 years to Visit 1 (week -3), except for non-melanoma skin cancer.
• Subject has a contraindication to estrogen and/or progestin therapy or allergy/sensitivity to the use of estradiol and/or progesterone, soy, or any components in the study product.
• Subject has used estrogen alone or estrogen/progestin, selective estrogen receptor modulator, testosterone, or estrogen/testosterone within 30 d prior to Visit 1 (week -3).
• Subject has used any prescription or over-the-counter products/supplements (e.g., soy products, herbal supplements) that have potential to alter progesterone or estrogen activity or is being used to treat VMS within 30 d prior to Visit 1 (week -3).
• Subject has self-described extreme or irregular dietary habits, in the opinion of the Clinical Investigator or has been diagnosed with an eating disorder.
• Subject has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
• Subject has been exposed to any non-registered drug product or has participated in another intervention study within 30 d prior to Visit 1 (week -3).
• Subject has a recent history of (within 12 months of screening; Visit 1; week -3) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).

Sponsors & Collaborators

• Pharmavite LLC: lead
• Biofortis, Merieux NutriSciences: collaborator

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60601, United States

Location

MeSH Terms

Interventions

Equol

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: March 27, 2019
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)