MenopausePhase 2NCT00302731
Bioidentical 'Natural' Hormone Evaluation in Early Menopause
A Phase 2 study testing Estradiol , estriol , progesterone, estradiol, progesterone and estriol, progesterone in people with Menopause, run by Jeanne Drisko, MD, CNS, FACN at 1 site in United States.
Trial summary
Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information about safety when "natural" or bioidentical hormones are used during early menopause. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Estradiol , estriol , progesterone, estradiol, progesterone and estriol, progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Ambulatory
- Within 7 years post menopause
- Positive history of menopausal symptoms such as vasomotor symptoms or osteoporosis in a study subject unable to tolerate bisphosphonates
- FSH greater than 20 mIU/mL
- Intact uterus and at least one intact ovary
Show all 11Show fewer
- Amenorrhea for 3 months or greater up to 7 years
- Normal pap smear results within 12 months
- Normal mammogram result within 12 months
- Agreeable to a 3 month washout period with no hormones prior to entering the trial
- Women who have no language barrier, are cooperative, and who can give informed consent before entering this study
Who cannot join
- Unwilling to take hormone replacement for the 12 month period
- Evidence of clinically significant psychiatric disorder by history/examination that would prevent the patient from completing the study.
- Active deep venous thrombosis, pulmonary embolism, or a history of these conditions
- Active or recent arterial thromboembolic disease
- Undiagnosed vaginal bleeding
- Hypersensitivity to ingredients in Prempro
Show all 32Show fewer
- Patients with known current bone disorders other than primary osteoporosis
- Patients with pathological fractures
- Patients with suspected or history of carcinoma of the breast or estrogen dependent neoplasms such as endometrial carcinoma.
- Patients who have ≥ 5mm endometrial thickness by endovaginal (transvaginal) ultrasound.
- Patients who have impaired renal function evidenced by serum creatinine greater than 2.5 mg/dL.
- Patients who have impaired hepatic function evidenced by transaminase (AST/ALT) ≥2.5X upper limit
- Patients with severe malabsorption syndromes.
- Patients who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one or combination of the following per day: 30 mL distilled spirits, 340 mL beer, or 120 mL wine).
- Treatment with therapeutic doses of any of the following medications more recently than 3 months:
- Estrogen
- Calcitonin
- Corticosteroids
- Progestins
- Progesterone
- Lithium
- Androgen
- Heparin
- Herbal menopause treatments
- SERMS
- Fluorides
- Phosphate binding antacids
- Bisphosphonates
- Vitamin D 50,000IU
- Anticonvulsants
- Patients who received any investigational drug within the proceeding month
- Tobacco use will not be allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Prospective Double Blind Evaluation of Bioidentical Hormones
Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information about safety when "natural" or bioidentical hormones are used during early menopause.
Read the detailed description
In spite of warnings regarding safety and adverse events widely publicized after the Women's Health Initiative (WHI), women continue to seek hormone replacement therapy for a variety of reasons. Increased cardiovascular events identified in WHI are an important concern for considering menopausal hormone replacement. There is the belief the 'natural' or bioidentical hormone replacement therapy could provide a safe alternative to widely used synthetic hormone replacement therapy. However, this has never been studied with any rigor and health care providers can not adequately advise patients seeking 'natural' bioidentical hormone therapy.
This feasibility pilot study is designed as a prospective double blind study comparing 4 groups of women who are within 7 years of menopause. There will be 10 women in each of the 4 groups with a total of 40 women enrolled and these women will be treated for 12 months.
The Long-Term Goal is to provide health care practitioners and consumers with evidence-based recommendations for the use of bioidentical hormone replacement. The Short-Term Goal of this pilot study is to determine if it is feasible to conduct a study in bioidentical hormones and obtain information that could lead to a larger more definitive study. We would like to provide safety information for bioidentical hormone use by evaluating surrogate markers for cardiovascular disease (lipid levels), with secondary evaluation of breast (mammogram) and uterus (endovaginal ultrasound), and to collect information about bone preservation.
The information gained from this trial will provide information for a future trial to test the hypothesis that bioidentical hormone replacement therapy provides a safe alternative to standard hormone replacement therapy: To determine if bioidentical hormone replacement therapy is associated with improved lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro. This will be determined by evaluating lipid levels at baseline and during the 12-month treatment period.
Secondary hypotheses will also be evaluated in the future to include:
- To determine if bioidentical hormone replacement therapy provides improved short-term risk profiles for uterine and breast health when compared to Prempro. This will be accomplished by requiring mammograms and endovaginal ultrasounds at baseline and the end of the 12-month treatment period.
- To determine if there is bone loss when using bioidentical hormone replacement when compared to Prempro. This aim will be evaluated by Dexa bone scan at baseline and at 12 months.
Subjects will randomly be assigned to one of the four arms of the study for the 12 months of treatment. The standard of care arm will consist of 10 women receiving in a double blind fashion low-dose Prempro. There will be 3 treatment arms consisting of different combinations of E2 estradiol and/or E3 estriol, all combined with bioidentical progesterone. These 3 arms will each have 10 subjects randomized and the bioidentical hormone delivered in a double blind fashion. Since the gold standard for treatment is the conventional arm (Prempro), we will compare each bioidentical arms to the gold standard. This comparison will occur at the end of 12 months of treatment. In this pilot study, we also wish to collect preliminary data about the comparisons between the 3 bioidentical hormone arm and the conventional arm. This is necessary because there is currently anecdotal evidence that E3 alone without combination with E2 may constitute adequate therapy in spite of its low biological activity at the estrogen receptor. The use of high doses of E3 with or without E2 is in common use by complementary and alternative practitioners.
It is expected in this small pilot study that bioidentical hormone will provide an adequate short-term safety profile for cardiovascular, breast and uterine health that will provide guidance for a larger trial that is longer in duration. It is also expected that bone density may be maintained by bioidentical hormone replacement when compared to Prempro. There may not be sufficient numbers to determine significance between the control arm and the treatment arms; however, we expect to collect useful information for future trials. It is assumed that equivalence will not likely be determined based on the sample size.
- Conditions
- Menopause
- Being tested
- Estradiol , estriol , progesterone, estradiol, progesterone, estriol, progesterone, equine estrogens m-progesteroneacetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol , estriol , progesteroneDrug
Also called compounded bioidentical hormone
estradiol, progesteroneDrug
Also called compunded bioidentical hormone
estriol, progesteroneDrug
Also called compounded bioidentical hormone
equine estrogens m-progesteroneacetateDrug
Also called Premarin and Provera, Prempro
| Study group | Role | What they receive |
|---|---|---|
| 1 equine estrogens m-progesteroneacetate | Active comparator | Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Receives: Drug: equine estrogens m-progesteroneacetate |
| 2 estradiol estriol progesterone | Experimental | Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Receives: Drug: Estradiol , estriol , progesterone |
| 4 estradiol progesterone | Experimental | Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Receives: Drug: estradiol, progesterone |
| 3 estriol progesterone | Experimental | Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Receives: Drug: estriol, progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Cholesterol
To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion.
Measured: Baseline and month 12
Endometrial Measurement
Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion.
Measured: Baseline and month 12
Number of Participants Without Change in Baseline and Follow up Mammograms
Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below.
Measured: baseline and month 12
Secondary outcomes (1)
Number of Participants Without Change in Baseline and Follow up Bone Density
Comparison at baseline and month 12 by descriptive analysis of bone density. Assessing for changes in density related to hormone replacement therapy. Bone density readings for participants completing study in descriptive terms. Looking for significant change in bone density while on hormone therapy for 12 months. Those who had no change are counted below.
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeanne Drisko, MD, CNS, FACN
- Sponsor type
- University, hospital or other
- Collaborators
- Private Foundation through KU Endowment, University of Kansas
- Responsible party
- Sponsor-investigator, Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center
- Investigators
- Jeanne A Drisko, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302731
- Sponsor's protocol ID
- 9941
- Status last verified
- Jun 2018
- First submitted
- 10 Mar 2006
- Last updated
- 6 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Limited sample size and high drop out rate make data obtained of marginal value. We will decide on a case by case review if data will be made available to requesting researchers. We recognize that data sharing includes protected health information and the deserved rights of individuals who participate in research. We will make every effort to protect these data at all times. Such data intended for broader use will be free of identifiers that would permit linkages to individuals, research participants or variables that could lead to deductive disclosure of the identify of individual subjects. This is in accordance for "Standards for Privacy of Individually Identifiable Health Information" - The Privacy Rule - HHS dated August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double Blind Evaluation of Bioidentical Hormones
- ClinicalTrials.gov ID
- NCT00302731
- Acronym / sponsor ID
- 9941
- Conditions
- Menopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jeanne Drisko, MD, CNS, FACNUniversity, hospital or other
- Collaborators
- Private Foundation through KU Endowment, University of Kansas
- Study start
- Feb 2006
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Posted 16 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information about safety when "natural" or bioidentical hormones are used during early menopause.
Detailed description
In spite of warnings regarding safety and adverse events widely publicized after the Women's Health Initiative (WHI), women continue to seek hormone replacement therapy for a variety of reasons. Increased cardiovascular events identified in WHI are an important concern for considering menopausal hormone replacement. There is the belief the 'natural' or bioidentical hormone replacement therapy could provide a safe alternative to widely used synthetic hormone replacement therapy. However, this has never been studied with any rigor and health care providers can not adequately advise patients seeking 'natural' bioidentical hormone therapy.
This feasibility pilot study is designed as a prospective double blind study comparing 4 groups of women who are within 7 years of menopause. There will be 10 women in each of the 4 groups with a total of 40 women enrolled and these women will be treated for 12 months.
The Long-Term Goal is to provide health care practitioners and consumers with evidence-based recommendations for the use of bioidentical hormone replacement. The Short-Term Goal of this pilot study is to determine if it is feasible to conduct a study in bioidentical hormones and obtain information that could lead to a larger more definitive study. We would like to provide safety information for bioidentical hormone use by evaluating surrogate markers for cardiovascular disease (lipid levels), with secondary evaluation of breast (mammogram) and uterus (endovaginal ultrasound), and to collect information about bone preservation.
The information gained from this trial will provide information for a future trial to test the hypothesis that bioidentical hormone replacement therapy provides a safe alternative to standard hormone replacement therapy: To determine if bioidentical hormone replacement therapy is associated with improved lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro. This will be determined by evaluating lipid levels at baseline and during the 12-month treatment period.
Secondary hypotheses will also be evaluated in the future to include:
- To determine if bioidentical hormone replacement therapy provides improved short-term risk profiles for uterine and breast health when compared to Prempro. This will be accomplished by requiring mammograms and endovaginal ultrasounds at baseline and the end of the 12-month treatment period.
- To determine if there is bone loss when using bioidentical hormone replacement when compared to Prempro. This aim will be evaluated by Dexa bone scan at baseline and at 12 months.
Subjects will randomly be assigned to one of the four arms of the study for the 12 months of treatment. The standard of care arm will consist of 10 women receiving in a double blind fashion low-dose Prempro. There will be 3 treatment arms consisting of different combinations of E2 estradiol and/or E3 estriol, all combined with bioidentical progesterone. These 3 arms will each have 10 subjects randomized and the bioidentical hormone delivered in a double blind fashion. Since the gold standard for treatment is the conventional arm (Prempro), we will compare each bioidentical arms to the gold standard. This comparison will occur at the end of 12 months of treatment. In this pilot study, we also wish to collect preliminary data about the comparisons between the 3 bioidentical hormone arm and the conventional arm. This is necessary because there is currently anecdotal evidence that E3 alone without combination with E2 may constitute adequate therapy in spite of its low biological activity at the estrogen receptor. The use of high doses of E3 with or without E2 is in common use by complementary and alternative practitioners.
It is expected in this small pilot study that bioidentical hormone will provide an adequate short-term safety profile for cardiovascular, breast and uterine health that will provide guidance for a larger trial that is longer in duration. It is also expected that bone density may be maintained by bioidentical hormone replacement when compared to Prempro. There may not be sufficient numbers to determine significance between the control arm and the treatment arms; however, we expect to collect useful information for future trials. It is assumed that equivalence will not likely be determined based on the sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 equine estrogens m-progesteroneacetate | Active comparator | Drug: equine estrogens m-progesteroneacetateMenopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. |
| 2 estradiol estriol progesterone | Experimental | Drug: Estradiol , estriol , progesteroneMenopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. |
| 4 estradiol progesterone | Experimental | Drug: estradiol, progesteroneMenopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. |
| 3 estriol progesterone | Experimental | Drug: estriol, progesteroneMenopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- Ambulatory
- Within 7 years post menopause
- Positive history of menopausal symptoms such as vasomotor symptoms or osteoporosis in a study subject unable to tolerate bisphosphonates
- FSH greater than 20 mIU/mL
Key exclusion criteria (32 listed)
- Unwilling to take hormone replacement for the 12 month period
- Evidence of clinically significant psychiatric disorder by history/examination that would prevent the patient from completing the study.
- Active deep venous thrombosis, pulmonary embolism, or a history of these conditions
- Active or recent arterial thromboembolic disease
- Undiagnosed vaginal bleeding
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 |
|---|---|---|
| Estradiol , estriol , progesteroneAlso: compounded bioidentical hormone | Drug | 2 estradiol estriol progesterone |
| estradiol, progesteroneAlso: compunded bioidentical hormone | Drug | 4 estradiol progesterone |
| estriol, progesteroneAlso: compounded bioidentical hormone | Drug | 3 estriol progesterone |
| equine estrogens m-progesteroneacetateAlso: Premarin and Provera, Prempro | Drug | 1 equine estrogens m-progesteroneacetate |
Primary outcome
Change in Total Cholesterol
Time frame: Baseline and month 12
To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion.
Endometrial Measurement
Time frame: Baseline and month 12
Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion.
Number of Participants Without Change in Baseline and Follow up Mammograms
Time frame: baseline and month 12
Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below.
1 secondary outcome
Number of Participants Without Change in Baseline and Follow up Bone Density
Time frame: baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Limited sample size and high drop out rate make data obtained of marginal value. We will decide on a case by case review if data will be made available to requesting researchers. We recognize that data sharing includes protected health information and the deserved rights of individuals who participate in research. We will make every effort to protect these data at all times. Such data intended for broader use will be free of identifiers that would permit linkages to individuals, research participants or variables that could lead to deductive disclosure of the identify of individual subjects. This is in accordance for "Standards for Privacy of Individually Identifiable Health Information" - The Privacy Rule - HHS dated August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information.
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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.
Jeanne A Drisko, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estradiol , estriol , progesterone, estradiol, progesterone and estriol, progesterone in people with Menopause, run by Jeanne Drisko, MD, CNS, FACN 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 11 inclusion and 32 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: stopped early, as of the sponsor's last update on 6 Jul 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Total Cholesterol (time frame: Baseline and month 12). 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 6 Jul 2018.