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CompletedNCT06787443Updated Jan 22, 2025

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

An interventional study of Placebo and Dietary Supplement with Proprietary Herbal Extract Blend and GABA in Menopausal Symptoms, 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 2025-01-22.

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

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2024, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Menopausal Symptoms
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
  • 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
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
88 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

  • Active comparator
    Dietary Supplement with Actives

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

Interventions

  • Dietary supplementPlacebo

    Eligible subjects will receive Placebo to take daily for five weeks

  • Dietary supplementDietary Supplement with Proprietary Herbal Extract Blend and GABA

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

06

What researchers measure

Primary outcomes

  1. Changes of symptom scores in Daily Dairy

    To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects

    Time frame: from enrollment to the end of study at five weeks

  2. Changes of symptom scores in Mobile Application

    To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects

    Time frame: from enrollment to the end of study at five weeks

Secondary outcomes

  1. Changes in Menopause-Specific Quality of Life (MENQOL) Scores

    To assess changes in mood and quality of life scores of the product compared to placebo

    Time frame: from enrollment to the end of study at five weeks

  2. Changes in Green Climacteric Scale (GCS) Scores

    To assess changes in mood scores of the product compared to placebo

    Time frame: from enrollment to the end of study at five weeks

  3. Changes in Perceived Stress Scale (PSS) Scores

    To assess changes in mood scores of the product compared to placebo

    Time frame: from enrollment to the end of study at five weeks

  4. Changes in Profile of Mood States (POMS) Scores

    To assess changes in mood scores of the product compared to placebo

    Time frame: from enrollment to the end of study at five weeks

  5. Changes in Pittsburgh Sleep Quality Index (PSQI) Scores

    To assess changes in sleep scores of the product compared to placebo

    Time frame: from enrollment to the end of study at five weeks

07

Study locations

1 site
  • See Final Report
    San Francisco, California 94127, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06787443
Lead sponsor
Olly, PBC
Responsible party
Sponsor
First posted
Jan 22, 2025
Start date
May 10, 2024
Primary completion
Jun 24, 2024
Completion
Jun 24, 2024
Last update
Jan 22, 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 Jan 2025. You cannot join it, but the record below documents what was studied.

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