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

Menopause Clinical Trial

— REVERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862861
• Other study ID #: Medimix Pharm-02
• Status: Completed
• Phase: N/A
• First received: May 22, 2013
• Last updated: July 30, 2014
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Medimix Specialty Pharmacy, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menopause

Locations

Country	Name	City	State
United States	The Medimix Specialty Pharmacy, LLC	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medimix Specialty Pharmacy, LLC

Country where clinical trial is conducted

United States, 

References & Publications (14)

Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2012.

Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, Sternfeld B, Matthews K. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006 Jul;96(7):1226-35. Epub 2006 May 30. — View Citation

Heinemann LA, DoMinh T, Strelow F, Gerbsch S, Schnitker J, Schneider HP. The Menopause Rating Scale (MRS) as outcome measure for hormone treatment? A validation study. Health Qual Life Outcomes. 2004 Nov 22;2:67. — View Citation

Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949. Review. — View Citation

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.

Julious SA, Campbell MJ, Altman DG. Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat. 1999 May;9(2):241-51. — View Citation

Julious SA, Campbell MJ. Sample size calculations for paired or matched ordinal data. Stat Med. 1998 Jul 30;17(14):1635-42. — View Citation

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

Lorentzen J. Hormone replacement therapy: part 1 - the evolution of hormone treatment. Int J Pharm Compd. 2001 Sep-Oct;5(5):336-8. — View Citation

Maclennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD002978. Review. — View Citation

Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8;11:27. doi: 10.1186/1472-6874-11-27. — View Citation

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.

Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006. Review. — View Citation

Wepfer ST. The science behind hormone replacement therapy, part ! Int J Pharm Compd. 2001 Nov-Dec;5(6):462-4. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.	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	No
Secondary	To evaluate health-related quality of life (HrQol)	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	No