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

Physician Recommended Nutriceuticals2 sites in 1 country20 target enrollmentMarch 2015

ConditionsMenopause

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Menopause
Sponsor: Physician Recommended Nutriceuticals
Enrollment: 20
Locations: 2
Primary Endpoint: Hot flashes episodes
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

March 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Physician Recommended Nutriceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.