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

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.

Study Overview

• Status: Terminated
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: proprietary formula

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Comprehensive Women's Care
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19148
      • Dittrich Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; all natural dietary supplement	Dietary supplement: proprietary formula
Other: Treatment + Omega-3s; all natural dietary supplement + omega-3s	Dietary supplement: proprietary formula
Placebo Comparator: Placebo; vegetable oil	Dietary supplement: proprietary formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot flashes episodes	Diary	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Questionnaire	12 weeks
Work productivity	Questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Physician Recommended Nutriceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PRN 20144