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

NCT ID: NCT02497560

Last Updated: 2016-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment

all natural dietary supplement

Group Type ACTIVE_COMPARATOR

proprietary formula

Intervention Type DIETARY_SUPPLEMENT

Treatment + Omega-3s

all natural dietary supplement + omega-3s

Group Type OTHER

proprietary formula

Intervention Type DIETARY_SUPPLEMENT

Placebo

vegetable oil

Group Type PLACEBO_COMPARATOR

proprietary formula

Intervention Type DIETARY_SUPPLEMENT

Interventions

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proprietary formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Physician Recommended Nutriceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Comprehensive Women's Care

Colorado Springs, Colorado, United States

Site Status

Dittrich Clinic

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRN 20144

Identifier Type: -

Identifier Source: org_study_id

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