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

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ClinicalTrials.gov Identifier: NCT01862861
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Medimix Specialty Pharmacy, LLC

Brief Summary:
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.

Condition or disease
Menopause

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

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Study Start Date : November 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862861


Locations
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United States, Florida
The Medimix Specialty Pharmacy, LLC
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Medimix Specialty Pharmacy, LLC
Investigators
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Study Chair: Benjamin J Epstein, PharmD The Medimix Specialty Pharmacy, LLC

Publications:
Levin ER, Hammes SR.Chapter 40. Estrogens and Progestins. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http://www.accesspharmacy.com/content.aspx?aID=16673417. Accessed September 28, 2012
Snyder PJ. Chapter41. Androgens. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gillman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http;//www.accesspharmacy.com/content.aspx?aID=16673856. Accessed September 28,2012.
Hunter MS, The Women's Health Questionnaire (WHQ): the development, standardization and application of a measure of mid-aged women's emotional and physical health. Quality of Life Res. 2000;9(1):733-738.
Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2012.

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Responsible Party: Medimix Specialty Pharmacy, LLC
ClinicalTrials.gov Identifier: NCT01862861     History of Changes
Other Study ID Numbers: Medimix Pharm-02
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Medimix Specialty Pharmacy, LLC:
Bioidentical Hormone Replacement Therapy

Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs