Status:
COMPLETED
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Lead Sponsor:
Medimix Specialty Pharmacy, LLC
Conditions:
Menopause
Eligibility:
FEMALE
30-65 years
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-men...
Detailed Description
Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01862861
Start Date
November 1 2012
End Date
July 1 2013
Last Update
July 31 2014
Active Locations (1)
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1
The Medimix Specialty Pharmacy, LLC
Jacksonville, Florida, United States, 32216