One Week Clinical Study in Subjects With Menopausal Symptoms

Last updated: July 11, 2025
Sponsor: Olly, PBC
Overall Status: Completed

Phase

N/A

Condition

Menopause

Treatment

Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Placebo

Clinical Study ID

NCT06794021
UNLV20241205
  • Ages 40-65
  • Female
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are:

  1. To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application

  2. To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application

  3. To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL).

  4. To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy Females aged 40 to 65 years,

  • Self-reporting menopausal symptoms (> 5 hot flushes per day) and have been presentfor 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 scheduledvisits.

Exclusion

Exclusion Criteria:

  • Pregnancy or breastfeeding.

  • Immune insufficiency

  • Women of childbearing potential including those still having a menstrual cycle on aregular 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 thesubject'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; adisease or condition that could influence the participants' ability to follow thestudy 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 supplementintake will be registered prior to inclusion in the study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Dietary Supplement with Proprietary Herbal Extract Blend and GABA
Phase:
Study Start date:
January 21, 2025
Estimated Completion Date:
April 22, 2025

Connect with a study center

  • San Francisco Research Institute

    San Francisco, California 94127
    United States

    Site Not Available

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