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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01862861

Acronym

REVERT

Enrollment

Registered

2013-05-27

Start date

2012-11-30

Completion date

2013-07-31

Last updated

2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Bioidentical Hormone Replacement Therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results