CClinicalTrials.gg
CompletedNCT06794021Updated Jul 15, 2025

One Week Clinical Study in Subjects With Menopausal Symptoms

An interventional study of Dietary Supplement with Proprietary Herbal Extract Blend and GABA and Placebo in Healthy and Menopause, sponsored by Olly, PBC. Completed at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by Olly, PBC · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

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)
02

Conditions studied

  • Healthy
  • Menopause
03

In context

Lead sponsor

Olly, PBC is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Oral dietary supplement. Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

    Other: Placebo

  • Active comparator
    Dietary Supplement with Proprietary Herbal Extract Blend and GABA

    Oral dietary supplement. Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

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

Interventions

  • Dietary supplementDietary Supplement with Proprietary Herbal Extract Blend and GABA

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

  • OtherPlacebo

    Eligible subjects will receive Placebo to take daily for seven days

06

What researchers measure

Primary outcomes

  1. Daily Diary - 24hr

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

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

  2. Mobile App - 24hr

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

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

Secondary outcomes

  1. Daily Dairy - Days 1-6

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

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

  2. Mobile App - Days 1-6

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

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

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

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

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

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

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

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

Other outcomes

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

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

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

  2. Perceived Stress Scale (PSS) - Day 7

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

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

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

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

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

07

Study locations

1 site
  • San Francisco Research Institute
    San Francisco, California 94127, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06794021
Lead sponsor
Olly, PBC
Responsible party
Sponsor
First posted
Jan 27, 2025
Start date
Jan 21, 2025
Primary completion
Jan 31, 2025
Completion
Apr 22, 2025
Last update
Jul 15, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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