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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02497560
• Other study ID #: PRN 20144
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 6, 2015
• Last updated: August 2, 2016
• Start date: March 2015

Study information

• Verified date: August 2016
• Source: Physician Recommended Nutriceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• proprietary formula

Locations

Country	Name	City	State
United States	Comprehensive Women's Care	Colorado Springs	Colorado
United States	Dittrich Clinic	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Physician Recommended Nutriceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flashes episodes	Diary	12 weeks	No
Secondary	Work productivity	Questionnaire	12 weeks	No
Secondary	Quality of Life	Questionnaire	12 weeks	No