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CompletedNCT01862861REVERTUpdated Jul 31, 2014

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

An observational study in Menopause, sponsored by Medimix Specialty Pharmacy, LLC. Completed at 1 site in United States. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-07-31.

Sponsored by Medimix Specialty Pharmacy, LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
69
Ages
30 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Menopause

Keywords

  • Bioidentical Hormone Replacement Therapy
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In context

Lead sponsor

Medimix Specialty Pharmacy, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
69 participants (actual)
Patient registry
No

Groups and cohorts

  • Peri or post-menopausal women.

    Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 Week Study

Secondary outcomes

  1. 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.

    Time frame: 12 Weeks

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Study locations

1 site
  • The Medimix Specialty Pharmacy, LLC
    Jacksonville, Florida 32216, United States
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References and documents

Publications

  • Wepfer ST. The science behind hormone replacement therapy, part ! Int J Pharm Compd. 2001 Nov-Dec;5(6):462-4. No abstract available. PubMed 23982041 ↗
  • 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. PubMed 19179815 ↗
  • Lorentzen J. Hormone replacement therapy: part 1 - the evolution of hormone treatment. Int J Pharm Compd. 2001 Sep-Oct;5(5):336-8. No abstract available. PubMed 23981968 ↗
  • 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. PubMed 21651797 ↗
  • 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. PubMed 21961716 ↗
  • 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. doi: 10.2105/AJPH.2005.066936. Epub 2006 May 30. PubMed 16735636 ↗
  • 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.
  • 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;2004(4):CD002978. doi: 10.1002/14651858.CD002978.pub2. PubMed 15495039 ↗
  • 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. doi: 10.1186/1477-7525-2-67. PubMed 15555079 ↗
  • 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.
  • Julious SA, Campbell MJ. Sample size calculations for paired or matched ordinal data. Stat Med. 1998 Jul 30;17(14):1635-42. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-k. PubMed 9699235 ↗
  • 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. doi: 10.1081/BIP-100101174. PubMed 10379691 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2013
First posted
May 27, 2013
Start
Nov 2012
Primary completionActual
Jul 2013
CompletionActual
Jul 2013
Last update
Jul 31, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01862861
Lead sponsor
Medimix Specialty Pharmacy, LLC
Responsible party
Sponsor
First posted
May 27, 2013
Start date
Nov 2012
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 31, 2014

Study contacts

Benjamin J Epstein, PharmD
study chair · The Medimix Specialty Pharmacy, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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