A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms



Status:Suspended
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:45 - 65
Updated:4/21/2016
Start Date:March 2015

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A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms

This is a randomized, masked, placebo controlled study to assess the effect on a nutritional
dietary supplement on menopausal signs and symptoms in perimenopausal women.


Inclusion Criteria:

- Age group between 45 and 65 at the time of informed consent.

- Physician diagnosis of menopause.

- History of substantial hot flashes > 4 episodes /day for last 2 weeks.

- Being post-menopausal with an intact uterus.

- Subject has provided signed and dated written informed consent before admission to
the study.

Exclusion Criteria:

- Concurrent hot flash therapies (prescription medications including hormone
replacement therapies, gabapentin or over the counter supplements), vaginal hormonal
products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products
for 30 days before screening visit.

- Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin
in the past 3 months, or expected to be on anticoagulants in the near future.

- Women involved in other clinical studies within the last 30 days.

- Any women who, in the opinion of the principal investigator, is at poor medical or
psychiatric risk for the study.
We found this trial at
2
sites
Colorado Springs, Colorado 80910
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Colorado Springs, CO
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3620 Locust Walk
Philadelphia, Pennsylvania 19148
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Philadelphia, PA
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