Clinical trial NCT06939868: Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women
Official title: Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: D008593
Keywords: menopause
hot flashes
supplement
Lead sponsor: Jacksonville University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 44
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a daily nutritional supplement can reduce hot flashes and other menopausal symptoms in postmenopausal women.

The main questions this study aims to answer are:

Does the supplement reduce the number and severity of daily hot flashes?

Does it improve other common menopausal symptoms?

Researchers will compare the supplement to a placebo (a look-alike capsule with no active ingredients) to see if it helps manage symptoms during menopause.

Participants will:

Take either the supplement or a placebo daily for 30 days

Track their hot flashes each day using a short online survey

Complete a symptom questionnaire at the beginning and end of the study

This study is for women ages 40-60 who have been postmenopausal for at least one year and currently experience bothersome hot flashes.

Detailed description: Purpose:

To evaluate the effectiveness of a nutritional supplement in reducing hot flash severity/frequency and menopausal symptoms in postmenopausal women.

Design:

Randomized, double-blind, placebo-controlled, two-arm, parallel-group trial over 30 days.

Participants:

Women aged 40-60 who are postmenopausal (≥1 year without menses) and report bothersome hot flashes (Menopause Rating Scale score ≥14, and hot flash severity of 3 or 4).

Exclusion Criteria:

Current hormone therapy or medications affecting hot flashes; significant comorbidities.

Intervention:

Group 1: Placebo

Group 2: Supplement

Assessments:

Daily self-reports of hot flash frequency/severity

Menopausal symptom assessments at baseline (Day 0) and post-intervention (Day 30)

Outcomes:

Primary: Hot flash severity and frequency

Secondary: Overall menopausal symptoms

Eligibility criteria: Inclusion Criteria:

* Adult women aged 40-60 years.
* Menopause Rating Scale score: (a) GE 14 and (b) score of 3 or 4 (severe to very severe) for hot flashes (Blumel et al., 2018).

Exclusion Criteria:

* Current use of hormone therapy or other medications known to affect hot flashes.
* Significant comorbidities that may interfere with study participation.

Primary outcomes:
measure: Composite hot flash score: Frequency × Severity
timeFrame: 30 days
Secondary outcomes:
measure: Menopause Rating Scale
timeFrame: 30 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville University
state: Florida
Study officials:
affiliation: Jacksonville University
name: Heather A Hausenblas, PhD
role: PRINCIPAL_INVESTIGATOR
References: