Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Menopause |
| Intervention | Not Provided |
| Phase | N/A |
| Sponsor | Medimix Specialty Pharmacy, LLC |
| Responsible Party | Medimix Specialty Pharmacy, LLC |
| ClinicalTrials.gov Identifier | NCT01862861 |
| First Received | May 22, 2013 |
| Last Updated | May 22, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 22, 2013 |
|---|---|
| Last Updated Date | May 22, 2013 |
| Start Date | November 2012 |
| Estimated Primary Completion Date | May 2014 |
| Current Primary Outcome Measures | To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms. [Time Frame: 12 Week Study] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures | To evaluate health-related quality of life (HrQol) [Time Frame: 12 Weeks] [Designated as safety issue: No]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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study |
|---|---|
| Official Title | Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study |
| 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 Type | Observational |
| Study Phase | N/A |
| Study Design | Observational Model: Cohort, Time Perspective: Prospective |
| Condition | Menopause |
| Intervention | Not Provided |
| Study Arm (s) | Peri or post-menopausal women. Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Enrolling by invitation |
|---|---|
| Estimated Enrollment | 69 |
| Estimated Completion Date | May 2014 |
| Estimated Primary Completion Date | May 2014 |
| Eligibility Criteria | 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. |
| Gender | Female |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01862861 |
|---|---|
| Other Study ID Numbers | Medimix Pharm-02 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Medimix Specialty Pharmacy, LLC |
| Study Sponsor | Medimix Specialty Pharmacy, LLC |
| Collaborators | Not Provided |
| Investigators | Study Chair: Benjamin J Epstein, PharmD The Medimix Specialty Pharmacy, LLC |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| The Medimix Specialty Pharmacy, LLC | Jacksonville, Florida, United States, 32216 |
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