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Completed

NCT Number: NCT06794021

One Week Clinical Study in Subjects With Menopausal Symptoms

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)

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Research Institute

San Francisco, California, 94127, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Dietary Supplement

Eligible subjects will receive active product to take daily for seven days

Placebo

Other

Eligible subjects will receive Placebo to take daily for seven days

Primary outcomes

  1. Daily Diary - 24hr

    Time frame: from enrollment to the end of study at seven days

    To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Daily Diary.

  2. Mobile App - 24hr

    Time frame: from enrollment to the end of study at seven days

    To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Mobile Application.

Secondary outcomes

  1. Daily Dairy - Days 1-6

    Time frame: from enrollment to the end of study at seven days

    To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6

  2. Mobile App - Days 1-6

    Time frame: from enrollment to the end of study at seven days

    To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6

  3. Green Climacteric Scale (GCS) - Days 1-6

    Time frame: from enrollment to the end of study at seven days

    To assess changes in stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6

  4. Menopause-Specific Quality of Life (MENQOL) - Days 1-6

    Time frame: from enrollment to the end of study at seven days

    To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6

Other outcomes

  1. Pittsburgh Sleep Quality Index (PSQI) - Day 7

    Time frame: from enrollment to the end of study at seven days

    To assess changes on mood, stress and sleep scores at 7 days post treatment

  2. Perceived Stress Scale (PSS) - Day 7

    Time frame: from enrollment to the end of study at seven days

    To assess changes on mood, stress and sleep scores at 7 days post treatment

  3. Profile of Mood States questionnaire (POMS) - Day 7

    Time frame: from enrollment to the end of study at seven days

    To assess changes on mood, stress and sleep scores at 7 days post treatment

Sponsors and collaborators

Lead sponsor

Olly, PBC

Industry

Registry information

Official study title

A One Week Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms Including Vasomotor Symptoms (VMS).

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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