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

NCT ID: NCT06787443

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2024-06-24

Brief Summary

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

Menopausal Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligible subjects will receive Placebo to take daily for five weeks

Dietary Supplement with Actives

Group Type: ACTIVE_COMPARATOR

Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Intervention Type: DIETARY_SUPPLEMENT

Eligible subjects will receive active product to take daily for five weeks

Interventions

Placebo

Eligible subjects will receive Placebo to take daily for five weeks

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Eligible subjects will receive active product to take daily for five weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Olly, PBC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

See Final Report

San Francisco, California, United States

Countries

United States

Other Identifiers

UNLV20240222

Identifier Type: -

Identifier Source: org_study_id