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

Eligible age

40–65 yrs

Accepts

Women

Locations

1 state

Healthy volunteers

Yes

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About this study

Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement

Sponsor: Olly, PBC

You may qualify if…

  • ✓ Healthy Females aged 40 to 65 years
  • ✓ Self-reporting menopausal symptoms (\> 5 hot flashes 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
  • ✓ NORMAL BMI (per metropolitan life tables): under 30 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.

You may not qualify if…

  • ✕ 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 panelist's health under risk, such as: thyroid disease, diabetes mellitus, history of hormone dependent (gynecological) cancer, endometrial hyperplasia, uterine cancer, endometrial cancer, drug and alcohol abuse, mental disorder, abnormality in renal and liver functions, personal or family history of breast cancer in a first degree relative, and history of clotting disorder such as deep vein thrombosis.)
  • ✕ 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

Where it's recruiting

California

San Francisco

Source: ClinicalTrials.gov · NCT07033013 · last updated 2025-07-16

A Randomized, Double Blind, Placebo Controlled, Clinical Study to Exam · TrialPath