Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study (REVERT)

July 30, 2014 updated by: Medimix Specialty Pharmacy, LLC
Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.

Study Overview

Status

Completed

Conditions

Detailed Description

Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • The Medimix Specialty Pharmacy, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.

Description

Inclusion Criteria:

  • Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician.
  • Participants must be starting a new regimen of bioidentical hormone replacement therapy.
  • Participants must be expected to receive therapy for at least 12 weeks.
  • Participants must be between 30 and 65 years of age.
  • Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.

Exclusion Criteria:

  • Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
  • Participants must not be pregnant or breastfeeding women.
  • Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy.
  • Participants must not be using another bioidentical hormone at the time of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Peri or post-menopausal women.
Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.
Time Frame: 12 Week Study
The reduction of severity of vasomotor symptoms will be evaluated by utilizing the Menopause Rating Scale (MRS) from baseline to the end of study at 12 weeks.
12 Week Study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate health-related quality of life (HrQol)
Time Frame: 12 Weeks
The quality of life (HrQol) will be evaluated by utilizing the Women's Health Questionnaire (WHQ)at baseline and at end of study at 12 weeks.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medimix Specialty Pharmacy, LLC

Investigators

  • Study Chair: Benjamin J Epstein, PharmD, The Medimix Specialty Pharmacy, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (ESTIMATE)

May 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Medimix Pharm-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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