NCT02497560

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 6, 2015

Last Update Submit

August 2, 2016

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

  • Hot flashes episodes

    Diary

    12 weeks

Secondary Outcomes (2)

  • Work productivity

    12 weeks

  • Quality of Life

    12 weeks

Study Arms (3)

Treatment

ACTIVE COMPARATOR

all natural dietary supplement

Dietary Supplement: proprietary formula

Treatment + Omega-3s

OTHER

all natural dietary supplement + omega-3s

Dietary Supplement: proprietary formula

Placebo

PLACEBO COMPARATOR

vegetable oil

Dietary Supplement: proprietary formula

Interventions

proprietary formulaDIETARY_SUPPLEMENT
PlaceboTreatmentTreatment + Omega-3s

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Comprehensive Women's Care

Colorado Springs, Colorado, 80910, United States

Location

Dittrich Clinic

Philadelphia, Pennsylvania, 19148, United States

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 14, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

US(2)