MenopausePhase 4NCT04190927
A New Hormone Replacement Paradigm: Physiologic Restoration Study
A Phase 4 study testing Compounded topical estradiol and compounded topical progesterone in a carrier cream in people with Menopause and Perimenopausal Disorder, run by Women's Hormone Network.
Trial summary
This is a three-year, prospective, observational study looking at the benefits of rhythmically dosed, bio-identical hormones compounded in a carrier cream in 100 symptomatic peri and postmenopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Perimenopausal Disorder, Menopause Related Conditions
- What is being tested?
- Compounded topical estradiol and compounded topical progesterone in a carrier cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Aug 2023
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Symptomatic perimenopausal or menopausal women as determined by symptoms, history, or labs that confirm menopause status.
- Any women interested in physiologic restoration for HRT replacement.
- Women with a history of breast, endometrial or ovarian cancer who are seeking HRT regardless of their diagnosis and recommendations not to have HRT. They must understand the risk and give informed dissent.
- Hysterectomy.
Who cannot join
- Women who are pregnant and or breastfeeding.
- Women who may be allergic to the base used for compounding.
- Previous recent (< 12 months) rhythmic dosing hormone protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A New Hormone Replacement Paradigm: Physiologic Restoration Using Compounded Biomimetic Estradiol, Progesterone and Testosterone Applied Transdermally in a Rhythmic Dose
This is a three-year, prospective, observational study looking at the benefits of rhythmically dosed, bio-identical hormones compounded in a carrier cream in 100 symptomatic peri and postmenopausal women. This study will measure changes in cognition, mood, quality of life, endocrine health, bone mineral density, and reduction of the symptoms of menopause and any adverse effects. The objectives of this study are to show that rhythmic dosing of bio-identical hormones that mimic a menstrual cycle, are possible, and may be more beneficial and have fewer side effects than the current standard of care for treating the symptoms of menopause.
Read the detailed description
"Bio-identical" hormones, which are compounded plant-based hormones synthesized into structurally similar to human estradiol and progesterone molecules, became popular in 2004 by celebrity, Suzanne Somers, who let women know there were natural alternatives to the drugs with hormone-like activity. Compounding hormones makes it easy to make dose adjustments in order to manage symptoms. Using this form of hormone delivery, it is possible to try and replicate a normal physiological reproductive pattern of replacement akin to thyroid replacement, etc. Current short-term studies with bio- identical transdermal estradiol and progesterone have not supported increased breast cancer or other issues such as venous thrombosis7. Even the WHI stated that the increase in breast cancer was due to stimulation of cancers already present.
This study of bio-identical physiologic restoration and dosing of estradiol, testosterone and cyclical transdermal progesterone attempts to replicate the reproductive hormone patterns and levels of a premenopausal woman. This dosing schedule has higher doses and levels than current standard estradiol and progesterone hormone therapy for post menopause women. Research shows that the estradiol peak of a menstrual cycle has an impact on cell signaling and receptor response. For example, TP53, the gene major tumor suppressor gene is under estrogen and progesterone control. At the peaks of estradiol and progesterone, TP53 is up regulated conferring cellular protection against mutations8-14.
Physiologic Restoration (PR) with bio-identical rhythmic dosing was originally developed by S.T. Wiley, who developed a template of hormone doses over time and was meant to be adjusted to the individual women depending on their symptoms and, absorption, metabolism, and response to the program. This study will utilize this concept with some improvements to the original proposed template (Sex, Lies, and Menopause, 2004). This regimen has been in national clinical practice since 2004 and has not been formally studied until now. There is unpublished observational data from Dr. Taguchi's high risk population of oncology patients (Santa Barbara Cottage Hospital IRB# 19-71ix) showing that PR is feasible and manages menopause symptoms well without seemingly more adverse effects and better sense of well being and excellent reversal or improvement of osteoporosis.
- Being tested
- Compounded topical estradiol and compounded topical progesterone in a carrier cream
- Keywords
- Menopause, Hormone Replacement Therapy, Bioidentical HRT, Transdermal HRT, Rhythmic Dosing, Physiologic Restoration, Biomimetic HRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compounded topical estradiol and compounded topical progesterone in a carrier creamBiological
Apply topical compounded estradiol and progesterone in the amount prescribed twice daily for each day of the 28 day lunar or menstrual cycle. Repeat each cycle month. Make note of any AE's so that modifications in dosing can be made.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All patients will be symptomatic peri or post menopausal and will all be started on the same protocol. The Dosing schedule of topical estradiol and topical progesterone will be modified for each subject in the first three months to address individual symptoms. The dosing will be relatively unique to each patient. Patients will remain on their dosing schedule for the remainder of the three year study and will be assessed during at the end of the study for changes in mood, symptoms of menopause, breast health, BMD and thickness of uterine lining . Receives: Biological: Compounded topical estradiol and compounded topical progesterone in a carrier cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptoms of Menopause
Measure changes in hormone levels and blood chemistry, assess changes in mood and cognitive function, measure changes in brain structure
Measured: 36 months
Compliance of this HRT Regimen
Measure compliance of patients on this specific HRT regimen
Measured: 36 months
Change in Bone Mineral Density
Bone Mineral Density will be monitored for changes
Measured: 36 months
Secondary outcomes (1)
Incidence of adverse effects
Measure incidence of cancer, embolism, coronary artery disease and stroke
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observational, single arm, prospective using a new dosing regimen of an existing biological drug.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hormone Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Taguchi, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190927
- Sponsor's protocol ID
- WHN 13/13
- Other IDs
- 19-71ix
- Status last verified
- Mar 2020
- First submitted
- 22 Nov 2019
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After all identifying information is removed from each patient's lab and study results, all results will be made available to the Women's Hormone Network so that they may be used for future study. Each patient will be identified by their last initial and year of birth (e.g. M1950) IPD to be shared are all lab results, blood work, BMD, mammogram, cognitive and mood questionnaires, and MRI, if applicable.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Hormone Replacement Paradigm: Physiologic Restoration Using Compounded Biomimetic Estradiol, Progesterone and Testosterone Applied Transdermally in a Rhythmic Dose
- ClinicalTrials.gov ID
- NCT04190927
- Acronym / sponsor ID
- WHN 13/13
- Keywords
- Menopause, Hormone Replacement Therapy, Bioidentical HRT, Transdermal HRT, Rhythmic Dosing, Physiologic Restoration, Biomimetic HRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Women's Hormone NetworkUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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.
This is a three-year, prospective, observational study looking at the benefits of rhythmically dosed, bio-identical hormones compounded in a carrier cream in 100 symptomatic peri and postmenopausal women. This study will measure changes in cognition, mood, quality of life, endocrine health, bone mineral density, and reduction of the symptoms of menopause and any adverse effects. The objectives of this study are to show that rhythmic dosing of bio-identical hormones that mimic a menstrual cycle, are possible, and may be more beneficial and have fewer side effects than the current standard of care for treating the symptoms of menopause.
Detailed description
"Bio-identical" hormones, which are compounded plant-based hormones synthesized into structurally similar to human estradiol and progesterone molecules, became popular in 2004 by celebrity, Suzanne Somers, who let women know there were natural alternatives to the drugs with hormone-like activity. Compounding hormones makes it easy to make dose adjustments in order to manage symptoms. Using this form of hormone delivery, it is possible to try and replicate a normal physiological reproductive pattern of replacement akin to thyroid replacement, etc. Current short-term studies with bio- identical transdermal estradiol and progesterone have not supported increased breast cancer or other issues such as venous thrombosis7. Even the WHI stated that the increase in breast cancer was due to stimulation of cancers already present.
This study of bio-identical physiologic restoration and dosing of estradiol, testosterone and cyclical transdermal progesterone attempts to replicate the reproductive hormone patterns and levels of a premenopausal woman. This dosing schedule has higher doses and levels than current standard estradiol and progesterone hormone therapy for post menopause women. Research shows that the estradiol peak of a menstrual cycle has an impact on cell signaling and receptor response. For example, TP53, the gene major tumor suppressor gene is under estrogen and progesterone control. At the peaks of estradiol and progesterone, TP53 is up regulated conferring cellular protection against mutations8-14.
Physiologic Restoration (PR) with bio-identical rhythmic dosing was originally developed by S.T. Wiley, who developed a template of hormone doses over time and was meant to be adjusted to the individual women depending on their symptoms and, absorption, metabolism, and response to the program. This study will utilize this concept with some improvements to the original proposed template (Sex, Lies, and Menopause, 2004). This regimen has been in national clinical practice since 2004 and has not been formally studied until now. There is unpublished observational data from Dr. Taguchi's high risk population of oncology patients (Santa Barbara Cottage Hospital IRB# 19-71ix) showing that PR is feasible and manages menopause symptoms well without seemingly more adverse effects and better sense of well being and excellent reversal or improvement of osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational, single arm, prospective using a new dosing regimen of an existing biological drug.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Compounded topical estradiol and compounded topical progesterone in a carrier creamAll patients will be symptomatic peri or post menopausal and will all be started on the same protocol. The Dosing schedule of topical estradiol and topical progesterone will be modified for each subject in the first three months to address individual symptoms. The dosing will be relatively unique to each patient. Patients will remain on their dosing schedule for the remainder of the three year study and will be assessed during at the end of the study for changes in mood, symptoms of menopause, breast health, BMD and thickness of uterine lining . |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic perimenopausal or menopausal women as determined by symptoms, history, or labs that confirm menopause status.
- Any women interested in physiologic restoration for HRT replacement.
- Women with a history of breast, endometrial or ovarian cancer who are seeking HRT regardless of their diagnosis and recommendations not to have HRT. They must understand the risk and give informed dissent.
- Hysterectomy.
Key exclusion criteria (3 listed)
- Women who are pregnant and or breastfeeding.
- Women who may be allergic to the base used for compounding.
- Previous recent (< 12 months) rhythmic dosing hormone protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compounded topical estradiol and compounded topical progesterone in a carrier creamApply topical compounded estradiol and progesterone in the amount prescribed twice daily for each day of the 28 day lunar or menstrual cycle. Repeat each cycle month. Make note of any AE's so that modifications in dosing can be made. | Biological | Treatment |
Primary outcome
Change in Symptoms of Menopause
Time frame: 36 months
Measure changes in hormone levels and blood chemistry, assess changes in mood and cognitive function, measure changes in brain structure
Compliance of this HRT Regimen
Time frame: 36 months
Measure compliance of patients on this specific HRT regimen
Change in Bone Mineral Density
Time frame: 36 months
Bone Mineral Density will be monitored for changes
1 secondary outcome
Incidence of adverse effects
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- website for the Women's Hormone NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After all identifying information is removed from each patient's lab and study results, all results will be made available to the Women's Hormone Network so that they may be used for future study. Each patient will be identified by their last initial and year of birth (e.g. M1950) IPD to be shared are all lab results, blood work, BMD, mammogram, cognitive and mood questionnaires, and MRI, if applicable.
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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.
Julie Taguchi, MD principal investigator
Principal Investigator
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compounded topical estradiol and compounded topical progesterone in a carrier cream in people with Menopause and Perimenopausal Disorder, run by Women's Hormone Network.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Taguchi, MD (805 879-0670, jtaguchi@womenshormonenetwork.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptoms of Menopause (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2020; AzTrials last refreshed its copy on 26 Oct 2026.