Randomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal Symptoms

What this trial studies

The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.

Conditions in scope

• Menopausal Symptoms

Interventions

• Placebo (Dietary Supplement) — Eligible subjects will receive Placebo to take daily for five weeks
• Dietary Supplement with Proprietary Herbal Extract Blend and GABA (Dietary Supplement) — Eligible subjects will receive active product to take daily for five weeks

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Healthy Females aged 40 to 65 years,
• Self-reporting menopausal symptoms (\> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
• Reporting a variable cycle length of \> 7 days different from normal
• BMI 20-40 kg/m2
• Able to read, understand, and complete the study questionnaire and records.
• Able to understand the study procedures.
• Able to comply with all study requirements.
• Written informed consent to participate in the study.

Exclusion criteria

• Pregnancy or breastfeeding.
• Immune insufficiency
• Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
• History of hysterectomy
• Women on hormone replacement therapy
• Use of systemic corticosteroids or immunosuppressant drugs.
• Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• Employees of the institute

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-05-10
• Primary completion: 2024-06-24
• Last update posted: 2025-01-22
• First posted: 2025-01-22

Sponsor & contact

Lead sponsor: Olly, PBC (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Changes of symptom scores in Daily Dairy (from enrollment to the end of study at five weeks)
  To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
• Changes of symptom scores in Mobile Application (from enrollment to the end of study at five weeks)
  To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.