One Week Clinical Study in Subjects With Menopausal Symptoms

Launched by OLLY, PBC · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how an oral product can help women experiencing menopausal symptoms, particularly hot flashes, mood swings, and anxiety. The study will track how effective this product is over one week by asking participants to keep daily diaries and use a mobile app to record their symptoms. They will compare the results of those taking the product to those taking a placebo (a non-active pill) to see if there are any differences in relief from these symptoms.

To be eligible for the study, women aged 40 to 65 who are generally healthy and experiencing at least five hot flashes a day for the past two months may participate. However, those who are pregnant, breastfeeding, or have certain medical conditions or treatments (like hormone replacement therapy) will be excluded. Participants can expect to visit the study site several times and will need to fill out questionnaires to help track their symptoms throughout the week. This is a great opportunity for those looking for potential relief from menopausal symptoms while contributing to important research.

Gender

FEMALE

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 or the brand owner or the manufactures of the product
• • 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
• • Use of other menopause supplements
• • BP ≥160/110 mmHg
• • Oophorectomy or amenorrhea \> two years. Note- Habitual medicine and supplement intake will be registered prior to inclusion in the study.