MenopauseREVERTNCT01862861
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
An observational study of Menopause, run by Medimix Specialty Pharmacy, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Menopause
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The Medimix Specialty Pharmacy, LLC
Jacksonville, Florida, 32216
About this study
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.
Read the detailed description
Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.
- Conditions
- Menopause
- Keywords
- Bioidentical Hormone Replacement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peri or post-menopausal women. | Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.
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.
Measured: 12 Week Study
Secondary outcomes (1)
To evaluate health-related quality of life (HrQol)
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medimix Specialty Pharmacy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin J Epstein, PharmD, Study chair, The Medimix Specialty Pharmacy, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862861
- Sponsor's protocol ID
- Medimix Pharm-02
- Acronym
- REVERT
- Status last verified
- Jul 2014
- First submitted
- 22 May 2013
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wepfer ST. The science behind hormone replacement therapy, part ! Int J Pharm Compd. 2001 Nov-Dec;5(6):462-4. No abstract available.
PubMed 23982041Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949.
PubMed 19179815Lorentzen J. Hormone replacement therapy: part 1 - the evolution of hormone treatment. Int J Pharm Compd. 2001 Sep-Oct;5(5):336-8. No abstract available.
PubMed 23981968Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8;11:27. doi: 10.1186/1472-6874-11-27.
PubMed 21651797Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006.
PubMed 21961716Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, Sternfeld B, Matthews K. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006 Jul;96(7):1226-35. doi: 10.2105/AJPH.2005.066936. Epub 2006 May 30.
PubMed 16735636Levin ER, Hammes SR.Chapter 40. Estrogens and Progestins. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http://www.accesspharmacy.com/content.aspx?aID=16673417. Accessed September 28, 2012
Snyder PJ. Chapter41. Androgens. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gillman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http;//www.accesspharmacy.com/content.aspx?aID=16673856. Accessed September 28,2012.
Maclennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD002978. doi: 10.1002/14651858.CD002978.pub2.
PubMed 15495039Heinemann LA, DoMinh T, Strelow F, Gerbsch S, Schnitker J, Schneider HP. The Menopause Rating Scale (MRS) as outcome measure for hormone treatment? A validation study. Health Qual Life Outcomes. 2004 Nov 22;2:67. doi: 10.1186/1477-7525-2-67.
PubMed 15555079Hunter MS, The Women's Health Questionnaire (WHQ): the development, standardization and application of a measure of mid-aged women's emotional and physical health. Quality of Life Res. 2000;9(1):733-738.
Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2012.
Julious SA, Campbell MJ. Sample size calculations for paired or matched ordinal data. Stat Med. 1998 Jul 30;17(14):1635-42. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-k.
PubMed 9699235Julious SA, Campbell MJ, Altman DG. Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat. 1999 May;9(2):241-51. doi: 10.1081/BIP-100101174.
PubMed 10379691
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
- ClinicalTrials.gov ID
- NCT01862861
- Acronym / sponsor ID
- REVERT / Medimix Pharm-02
- Conditions
- Menopause
- Keywords
- Bioidentical Hormone Replacement Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medimix Specialty Pharmacy, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peri or post-menopausal women. | – | –Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.
Time frame: 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.
1 secondary outcome
To evaluate health-related quality of life (HrQol)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Background: PubMed 23982041Wepfer ST. The science behind hormone replacement therapy, part ! Int J Pharm Compd. 2001 Nov-Dec;5(6):462-4. No abstract available.
- Background: PubMed 19179815Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949.
- Background: PubMed 23981968Lorentzen J. Hormone replacement therapy: part 1 - the evolution of hormone treatment. Int J Pharm Compd. 2001 Sep-Oct;5(5):336-8. No abstract available.
- Background: PubMed 21651797Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8;11:27. doi: 10.1186/1472-6874-11-27.
- Background: PubMed 21961716Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006.
- Background: PubMed 16735636Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, Sternfeld B, Matthews K. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006 Jul;96(7):1226-35. doi: 10.2105/AJPH.2005.066936. Epub 2006 May 30.
- BackgroundLevin ER, Hammes SR.Chapter 40. Estrogens and Progestins. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http://www.accesspharmacy.com/content.aspx?aID=16673417. Accessed September 28, 2012
- BackgroundSnyder PJ. Chapter41. Androgens. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gillman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http;//www.accesspharmacy.com/content.aspx?aID=16673856. Accessed September 28,2012.
- Background: PubMed 15495039Maclennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD002978. doi: 10.1002/14651858.CD002978.pub2.
- Background: PubMed 15555079Heinemann LA, DoMinh T, Strelow F, Gerbsch S, Schnitker J, Schneider HP. The Menopause Rating Scale (MRS) as outcome measure for hormone treatment? A validation study. Health Qual Life Outcomes. 2004 Nov 22;2:67. doi: 10.1186/1477-7525-2-67.
- BackgroundHunter MS, The Women's Health Questionnaire (WHQ): the development, standardization and application of a measure of mid-aged women's emotional and physical health. Quality of Life Res. 2000;9(1):733-738.
- BackgroundClinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin J Epstein, PharmD study chair
The Medimix Specialty Pharmacy, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Medimix Specialty Pharmacy, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms. (time frame: 12 Week Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862861, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.