Clinical trial NCT01862861: Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Official title: Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Keywords: Bioidentical Hormone Replacement Therapy
Lead sponsor: Medimix Specialty Pharmacy, LLC
Sponsor class: INDUSTRY
First posted: 2013-05-27
Enrollment: 69
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.

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.

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

Eligibility 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.

Primary outcomes:
measure: To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.
timeFrame: 12 Week Study
Secondary outcomes:
measure: To evaluate health-related quality of life (HrQol)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: The Medimix Specialty Pharmacy, LLC
state: Florida
Study officials:
affiliation: The Medimix Specialty Pharmacy, LLC
name: Benjamin J Epstein, PharmD
role: STUDY_CHAIR
References:
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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.
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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
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