San Francisco Research Institute
San Francisco, California, 94127, United States
NCT Number: NCT06794021
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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Inclusion criteria
Exclusion criteria
Eligible subjects will receive active product to take daily for seven days
Eligible subjects will receive Placebo to take daily for seven days
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.
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.
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
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
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
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
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
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
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
Olly, PBC
Industry
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).
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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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