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

Olly, PBC

Status: Completed

Conditions: Menopausal Symptoms

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Study type: Interventional

Funder types: Industry

Identifiers

NCT06787443

UNLV20240222

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: 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.
• Willingness to actively participate in the study and to come to the scheduled visits.

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
• Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
• Alcohol or drug abuse,
• Use of hormonal contraceptives within the last 3 months
• BP ≥160/110 mmHg
• Oophorectomy or amenorrhea > two years

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Dietary Supplement with Actives

Active Comparator group

Treatment:

Dietary Supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA