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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Menopause

In brief

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.

Key facts

Study ID

NCT02497560

Run by

Physician Recommended Nutriceuticals

People needed

20

Starts

2015-03-01

Last updated by the study team

2016-08-04

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Comprehensive Women's Care — Colorado Springs, Colorado, United States
• Dittrich Clinic — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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