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

Completed

• Conditions: Menopause

• Registration Number: NCT01862861
• Lead Sponsor: Medimix Specialty Pharmacy, LLC

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-27
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.	12 Week Study	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate health-related quality of life (HrQol)	12 Weeks	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.

Trial Locations

Locations (1)

The Medimix Specialty Pharmacy, LLC; 🇺🇸 Jacksonville, Florida, United States