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 |
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.
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.
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