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

Medimix Specialty Pharmacy, LLC

Status: Completed

Conditions: Menopause

Study type: Observational

Funder types: Industry

Identifiers

NCT01862861

Medimix Pharm-02

Details and patient eligibility

About

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.

Full description

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

Enrollment: 69 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

69 participants in 1 patient group

Peri or post-menopausal women.

Description:

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