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

Completed

Conditions studied: Menopause

In brief

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.

Key facts

Study ID

NCT01862861

Run by

Medimix Specialty Pharmacy, LLC

People needed

69

Starts

2012-11-01

Expected to finish

2013-07-01

Last updated by the study team

2014-07-31

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Medimix Specialty Pharmacy, LLC — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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