MenopauseNCT04453332
Effects of Hormone Replacement Therapy on Cardiovascular Risk and Body Composition Parameters
A study testing Oral hormone therapy (estradiol and micronized natural progesterone) and Non-oral hormone therapy (estradiol and micronized natural progesterone) in people with Menopause and Hormone Replacement Therapy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Menopause is defined as the last episode of menstrual bleeding, resulting from the interruption of ovarian function by follicular depletion. It is characterized by the presence of amenorrhea associated with increased levels of FSH and low levels of estradiol. Read more about this study
- Who is it for?
- Ages 40 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hormone Replacement Therapy
- What is being tested?
- Oral hormone therapy (estradiol and micronized natural progesterone) and Non-oral hormone therapy (estradiol and micronized natural progesterone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Oct 2015to Dec 2021
- Phase
- Interventional
- 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 40 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Six months or more of amenorrhea and FSH levels> or = at 35 mIU / ml;
- Menopause for a maximum of three years;
- Mammography and cytology of recent cervix (from the last 12 months);
- Signature of the Informed Consent Form.
Who cannot join
- Menopause age below 40 years;
- Use of hormonal therapy in the three months preceding the study;
- Uncontrolled diabetes mellitus;
- Endometrial thickening (endometrial thickness greater than 0.5 cm);
- Neoplasm of breast, colon or endometrium;
- History of thromboembolism or established cardiovascular disease;
Show all 9Show fewer
- Previous hysterectomy;
- Active smoking;
- Use of medication to treat osteoporosis in the last 12 months: bisphosphonates, denosumab, teriparatide, SERMs (selective estrogen receptor agonist).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
About this study
Official title: Effects of Oral and Non-oral Hormonal Therapy on Cardiovascular Risk and Body Composition Parameters in Postmenopausal Women
Menopause is defined as the last episode of menstrual bleeding, resulting from the interruption of ovarian function by follicular depletion. It is characterized by the presence of amenorrhea associated with increased levels of FSH and low levels of estradiol. The decline in estrogenic levels is associated with several organic changes, from vasomotor symptoms to impaired bone mass and urogenital atrophy. Although for some patients menopause is asymptomatic or oligosymptomatic, many women experience intense symptoms, which profoundly affect quality of life.
Proper assessment and treatment of postmenopausal women can significantly improve climacteric symptoms. Target tissue, hormone therapy regimen and variations between patients will influence the effects of treatment. Regarding estrogen, the main factors that influence the therapeutic response are the type of hormone used, the dose and the route of administration. The skin metabolizes only a small part of estradiol. Thus, the transdermal route reaches adequate therapeutic levels from a lower dose of estrogen.
The present study aims to evaluate and compare the effects of low dose of oral estradiol associated with oral progesterone and transdermal estradiol associated with vaginal progesterone on variables related to inflammation, coagulation and body composition parameters.
Read the detailed description
Hormone therapy (HT) was available since 1942 in tablets containing conjugated equine estrogens. Since the 1970s, it has been recommended to add progestogens to the treatment of women with a uterus to prevent endometrial hyperplasia. HT has been shown to be very effective in climacteric syndrome, relieving 90% of hot flushes that affect women in the menopausal transition.
Target tissue, HT regimen and variations between patients will influence the effects of treatment. Regarding estrogen, the main factors that influence the therapeutic response are the type of hormone used, the dose and the route of administration. The most physiological type of estrogen is 17β estradiol, available in the form of gel and adhesive. The skin metabolizes only a small part of estradiol. Thus, the transdermal route reaches adequate therapeutic levels from a lower dose of estrogen. Also, the transdermal route prevents the first hepatic passage, resulting in more stable levels of estradiol in the circulation, without supraphysiological liver concentrations. The bioavailability of estrogen after undergoing metabolism in the liver is approximately 2 to 10% of the total administered. This hepatic passage can result in greater variability in hormone levels, as well as activation of prothrombotic and inflammatory factors. In addition, hepatic metabolism can change the therapeutic effects of estrogen and other pharmacological agents.
The present study aims to evaluate and compare the effects of low dose of oral estradiol associated with oral progesterone and transdermal estradiol associated with vaginal progesterone on variables related to inflammation, coagulation and body composition parameters. This is a prospective randomized controlled study, and the study population includes postmenopausal patients with climacteric symptoms, who have not been using hormone therapy for at least three months. Patients will receive three months of oral hormonal treatment (estradiol 1mg and micronized natural progesterone 200mg 14 days a month) and three months of non-oral hormonal treatment (percutaneous estradiol gel 1.5mg and micronized progesterone 200mg vaginal 14 days a month).
Patients with climacteric symptoms who meet the inclusion and the exclusion criteria will be included in the study. The entire sample will receive both hormonal therapies sequentially and the patients will be divided between the groups (oral therapy and non-oral therapy) to start the study by random allocation. There will be no period of suspension between treatments, that is, at the end of the first three months of the study, the group initially treated with oral therapy starts receiving non-oral treatment for another three months, and the group initially treated with non-oral therapy starts to receive oral therapy also for another three months.
This project has already been approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre. Post-informed written consent will be obtained from all patients, in accordance with health research standards.
The results will be presented as means and standard deviation or medians and interquartile range. Analysis of variance for latin square will be used to evaluate carryover effect. Two-way ANOVA for repeated samples will be used to compare baseline conditions and the two treatments. Bonferroni's adjustment will be used for multiple comparisons. Bivariate correlations between continuous numerical variables will be examined using Pearson or Spearman correlation coefficients, according to the Gaussian or non-Gaussian nature of the variable, respectively. Statistical analysis will be performed using Statistical Package for Social Sciences (SPSS, Chicago, IL, USA), with a value of p <0.05 being considered significant.
- Conditions
- Menopause, Hormone Replacement Therapy
- Being tested
- Oral hormone therapy (estradiol and micronized natural progesterone), Non-oral hormone therapy (estradiol and micronized natural progesterone)
- Keywords
- Menopause, Hormone therapy, Body composition, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hormone therapy (estradiol and micronized natural progesterone)Drug
Oral hormone therapy - estradiol 1mg every day and micronized natural progesterone 200mg only 14 days a month
Non-oral hormone therapy (estradiol and micronized natural progesterone)Drug
Percutaneous estradiol gel 1.5mg every day and micronized progesterone 200mg vaginal only 14 days a month
| Study group | Role | What they receive |
|---|---|---|
| Oral hormone therapy | Active comparator | Estradiol 1mg and micronized natural progesterone 200mg 14 days a month (oral) Receives: Drug: Oral hormone therapy (estradiol and micronized natural progesterone) |
| Non-oral hormone therapy | Active comparator | Percutaneous estradiol gel 1.5mg and micronized progesterone 200mg vaginal 14 days a month (non-oral) Receives: Drug: Non-oral hormone therapy (estradiol and micronized natural progesterone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition parameters
Lean mass (kilograms) evaluated by dual energy X-ray absorptiometry (DXA)
Measured: Before hormone therapy and after 3 and 6 months of treatment
Change in body composition parameters
Fat mass (kilograms) evaluated by dual energy X-ray absorptiometry (DXA)
Measured: Before hormone therapy and after 3 and 6 months of treatment
Secondary outcomes (7)
Lipid profile
HDL, LDL, triglycerides (evaluated by blood sample)
Measured: Before hormone therapy and after 3 and 6 months of treatment
Serum glucose
(evaluated by blood sample)
Measured: Before hormone therapy and after 3 and 6 months of treatment
Blood pressure
Measured: Before hormone therapy and after 3 and 6 months of treatment
Weight
With body mass index (kg/m²)
Measured: Before hormone therapy and after 3 and 6 months of treatment
Physical activity
Evaluated by pedometer
Measured: Before hormone therapy and after 3 and 6 months of treatment
Bone mineral density (g/cm²)
Evaluated by dual energy X-ray absorptiometry (DXA)
Measured: Before hormone therapy and after 3 and 6 months of treatment
Bone metabolism
Calcium, phosphorus, PTH, albumin, 25 OH vitamin D (evaluated by blood sample)
Measured: Before hormone therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start9 Oct 2015
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective randomized controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poli Mara Spritzer, PhD, Principal investigator, Federal University of Rio Grande do Sul, Porto Alegre, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453332
- Sponsor's protocol ID
- 2015-0363
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LaCroix AZ, Chlebowski RT, Manson JE, Aragaki AK, Johnson KC, Martin L, Margolis KL, Stefanick ML, Brzyski R, Curb JD, Howard BV, Lewis CE, Wactawski-Wende J; WHI Investigators. Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. JAMA. 2011 Apr 6;305(13):1305-14. doi: 10.1001/jama.2011.382.
PubMed 21467283L'hermite M, Simoncini T, Fuller S, Genazzani AR. Could transdermal estradiol + progesterone be a safer postmenopausal HRT? A review. Maturitas. 2008 Jul-Aug;60(3-4):185-201. doi: 10.1016/j.maturitas.2008.07.007. Epub 2008 Sep 5.
PubMed 18775609Rovinski D, Ramos RB, Fighera TM, Casanova GK, Spritzer PM. Risk of venous thromboembolism events in postmenopausal women using oral versus non-oral hormone therapy: A systematic review and meta-analysis. Thromb Res. 2018 Aug;168:83-95. doi: 10.1016/j.thromres.2018.06.014. Epub 2018 Jun 19.
PubMed 29936403Modena MG, Sismondi P, Mueck AO, Kuttenn F, Lignieres Bd, Verhaeghe J, Foidart JM, Caufriez A, Genazzani AR; TREAT. New evidence regarding hormone replacement therapies is urgently required transdermal postmenopausal hormone therapy differs from oral hormone therapy in risks and benefits. Maturitas. 2005 Sep 16;52(1):1-10. doi: 10.1016/j.maturitas.2005.05.003.
PubMed 15963666Casanova G, Radavelli S, Lhullier F, Spritzer PM. Effects of nonoral estradiol-micronized progesterone or low-dose oral estradiol-drospirenone therapy on metabolic variables and markers of endothelial function in early postmenopause. Fertil Steril. 2009 Aug;92(2):605-12. doi: 10.1016/j.fertnstert.2008.06.049. Epub 2008 Aug 15.
PubMed 18706557Casanova G, Spritzer PM. Effects of micronized progesterone added to non-oral estradiol on lipids and cardiovascular risk factors in early postmenopause: a clinical trial. Lipids Health Dis. 2012 Oct 9;11:133. doi: 10.1186/1476-511X-11-133.
PubMed 23046709Lara S, Casanova G, Spritzer PM. Influence of habitual physical activity on body composition, fat distribution and metabolic variables in early postmenopausal women receiving hormonal therapy. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):52-6. doi: 10.1016/j.ejogrb.2010.02.007. Epub 2010 Feb 26.
PubMed 20189290Casanova G, Bossardi Ramos R, Ziegelmann P, Spritzer PM. Effects of low-dose versus placebo or conventional-dose postmenopausal hormone therapy on variables related to cardiovascular risk: a systematic review and meta-analyses of randomized clinical trials. J Clin Endocrinol Metab. 2015 Mar;100(3):1028-37. doi: 10.1210/jc.2014-3301. Epub 2014 Dec 16.
PubMed 25514104Goodman MP. Are all estrogens created equal? A review of oral vs. transdermal therapy. J Womens Health (Larchmt). 2012 Feb;21(2):161-9. doi: 10.1089/jwh.2011.2839. Epub 2011 Oct 19.
PubMed 22011208Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
PubMed 12117397
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral and Non-oral Hormonal Therapy on Cardiovascular Risk and Body Composition Parameters in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04453332
- Acronym / sponsor ID
- 2015-0363
- Conditions
- Menopause, Hormone Replacement Therapy
- Keywords
- Menopause, Hormone therapy, Body composition, Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 9 Oct 2015 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Jul 2020 (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.
Menopause is defined as the last episode of menstrual bleeding, resulting from the interruption of ovarian function by follicular depletion. It is characterized by the presence of amenorrhea associated with increased levels of FSH and low levels of estradiol. The decline in estrogenic levels is associated with several organic changes, from vasomotor symptoms to impaired bone mass and urogenital atrophy. Although for some patients menopause is asymptomatic or oligosymptomatic, many women experience intense symptoms, which profoundly affect quality of life.
Proper assessment and treatment of postmenopausal women can significantly improve climacteric symptoms. Target tissue, hormone therapy regimen and variations between patients will influence the effects of treatment. Regarding estrogen, the main factors that influence the therapeutic response are the type of hormone used, the dose and the route of administration. The skin metabolizes only a small part of estradiol. Thus, the transdermal route reaches adequate therapeutic levels from a lower dose of estrogen.
The present study aims to evaluate and compare the effects of low dose of oral estradiol associated with oral progesterone and transdermal estradiol associated with vaginal progesterone on variables related to inflammation, coagulation and body composition parameters.
Detailed description
Hormone therapy (HT) was available since 1942 in tablets containing conjugated equine estrogens. Since the 1970s, it has been recommended to add progestogens to the treatment of women with a uterus to prevent endometrial hyperplasia. HT has been shown to be very effective in climacteric syndrome, relieving 90% of hot flushes that affect women in the menopausal transition.
Target tissue, HT regimen and variations between patients will influence the effects of treatment. Regarding estrogen, the main factors that influence the therapeutic response are the type of hormone used, the dose and the route of administration. The most physiological type of estrogen is 17β estradiol, available in the form of gel and adhesive. The skin metabolizes only a small part of estradiol. Thus, the transdermal route reaches adequate therapeutic levels from a lower dose of estrogen. Also, the transdermal route prevents the first hepatic passage, resulting in more stable levels of estradiol in the circulation, without supraphysiological liver concentrations. The bioavailability of estrogen after undergoing metabolism in the liver is approximately 2 to 10% of the total administered. This hepatic passage can result in greater variability in hormone levels, as well as activation of prothrombotic and inflammatory factors. In addition, hepatic metabolism can change the therapeutic effects of estrogen and other pharmacological agents.
The present study aims to evaluate and compare the effects of low dose of oral estradiol associated with oral progesterone and transdermal estradiol associated with vaginal progesterone on variables related to inflammation, coagulation and body composition parameters. This is a prospective randomized controlled study, and the study population includes postmenopausal patients with climacteric symptoms, who have not been using hormone therapy for at least three months. Patients will receive three months of oral hormonal treatment (estradiol 1mg and micronized natural progesterone 200mg 14 days a month) and three months of non-oral hormonal treatment (percutaneous estradiol gel 1.5mg and micronized progesterone 200mg vaginal 14 days a month).
Patients with climacteric symptoms who meet the inclusion and the exclusion criteria will be included in the study. The entire sample will receive both hormonal therapies sequentially and the patients will be divided between the groups (oral therapy and non-oral therapy) to start the study by random allocation. There will be no period of suspension between treatments, that is, at the end of the first three months of the study, the group initially treated with oral therapy starts receiving non-oral treatment for another three months, and the group initially treated with non-oral therapy starts to receive oral therapy also for another three months.
This project has already been approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre. Post-informed written consent will be obtained from all patients, in accordance with health research standards.
The results will be presented as means and standard deviation or medians and interquartile range. Analysis of variance for latin square will be used to evaluate carryover effect. Two-way ANOVA for repeated samples will be used to compare baseline conditions and the two treatments. Bonferroni's adjustment will be used for multiple comparisons. Bivariate correlations between continuous numerical variables will be examined using Pearson or Spearman correlation coefficients, according to the Gaussian or non-Gaussian nature of the variable, respectively. Statistical analysis will be performed using Statistical Package for Social Sciences (SPSS, Chicago, IL, USA), with a value of p <0.05 being considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Oral hormone therapy | Active comparator | Drug: Oral hormone therapy (estradiol and micronized natural progesterone)Estradiol 1mg and micronized natural progesterone 200mg 14 days a month (oral) |
| Non-oral hormone therapy | Active comparator | Drug: Non-oral hormone therapy (estradiol and micronized natural progesterone)Percutaneous estradiol gel 1.5mg and micronized progesterone 200mg vaginal 14 days a month (non-oral) |
Who may qualify
- Ages
- 40 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Six months or more of amenorrhea and FSH levels> or = at 35 mIU / ml;
- Menopause for a maximum of three years;
- Mammography and cytology of recent cervix (from the last 12 months);
- Signature of the Informed Consent Form.
Key exclusion criteria (9 listed)
- Menopause age below 40 years;
- Use of hormonal therapy in the three months preceding the study;
- Uncontrolled diabetes mellitus;
- Endometrial thickening (endometrial thickness greater than 0.5 cm);
- Neoplasm of breast, colon or endometrium;
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 |
|---|---|---|
| Oral hormone therapy (estradiol and micronized natural progesterone)Oral hormone therapy - estradiol 1mg every day and micronized natural progesterone 200mg only 14 days a month | Drug | Oral hormone therapy |
| Non-oral hormone therapy (estradiol and micronized natural progesterone)Percutaneous estradiol gel 1.5mg every day and micronized progesterone 200mg vaginal only 14 days a month | Drug | Non-oral hormone therapy |
Primary outcome
Change in body composition parameters
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Lean mass (kilograms) evaluated by dual energy X-ray absorptiometry (DXA)
Change in body composition parameters
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Fat mass (kilograms) evaluated by dual energy X-ray absorptiometry (DXA)
7 secondary outcomes
Lipid profile
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Serum glucose
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Blood pressure
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Weight
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Physical activity
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Bone mineral density (g/cm²)
Time frame: Before hormone therapy and after 3 and 6 months of treatment
Bone metabolism
Time frame: Before hormone therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Background: PubMed 21467283LaCroix AZ, Chlebowski RT, Manson JE, Aragaki AK, Johnson KC, Martin L, Margolis KL, Stefanick ML, Brzyski R, Curb JD, Howard BV, Lewis CE, Wactawski-Wende J; WHI Investigators. Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. JAMA. 2011 Apr 6;305(13):1305-14. doi: 10.1001/jama.2011.382.
- Background: PubMed 18775609L'hermite M, Simoncini T, Fuller S, Genazzani AR. Could transdermal estradiol + progesterone be a safer postmenopausal HRT? A review. Maturitas. 2008 Jul-Aug;60(3-4):185-201. doi: 10.1016/j.maturitas.2008.07.007. Epub 2008 Sep 5.
- Background: PubMed 29936403Rovinski D, Ramos RB, Fighera TM, Casanova GK, Spritzer PM. Risk of venous thromboembolism events in postmenopausal women using oral versus non-oral hormone therapy: A systematic review and meta-analysis. Thromb Res. 2018 Aug;168:83-95. doi: 10.1016/j.thromres.2018.06.014. Epub 2018 Jun 19.
- Background: PubMed 15963666Modena MG, Sismondi P, Mueck AO, Kuttenn F, Lignieres Bd, Verhaeghe J, Foidart JM, Caufriez A, Genazzani AR; TREAT. New evidence regarding hormone replacement therapies is urgently required transdermal postmenopausal hormone therapy differs from oral hormone therapy in risks and benefits. Maturitas. 2005 Sep 16;52(1):1-10. doi: 10.1016/j.maturitas.2005.05.003.
- Background: PubMed 18706557Casanova G, Radavelli S, Lhullier F, Spritzer PM. Effects of nonoral estradiol-micronized progesterone or low-dose oral estradiol-drospirenone therapy on metabolic variables and markers of endothelial function in early postmenopause. Fertil Steril. 2009 Aug;92(2):605-12. doi: 10.1016/j.fertnstert.2008.06.049. Epub 2008 Aug 15.
- Background: PubMed 23046709Casanova G, Spritzer PM. Effects of micronized progesterone added to non-oral estradiol on lipids and cardiovascular risk factors in early postmenopause: a clinical trial. Lipids Health Dis. 2012 Oct 9;11:133. doi: 10.1186/1476-511X-11-133.
- Background: PubMed 20189290Lara S, Casanova G, Spritzer PM. Influence of habitual physical activity on body composition, fat distribution and metabolic variables in early postmenopausal women receiving hormonal therapy. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):52-6. doi: 10.1016/j.ejogrb.2010.02.007. Epub 2010 Feb 26.
- Background: PubMed 25514104Casanova G, Bossardi Ramos R, Ziegelmann P, Spritzer PM. Effects of low-dose versus placebo or conventional-dose postmenopausal hormone therapy on variables related to cardiovascular risk: a systematic review and meta-analyses of randomized clinical trials. J Clin Endocrinol Metab. 2015 Mar;100(3):1028-37. doi: 10.1210/jc.2014-3301. Epub 2014 Dec 16.
- Background: PubMed 22011208Goodman MP. Are all estrogens created equal? A review of oral vs. transdermal therapy. J Womens Health (Larchmt). 2012 Feb;21(2):161-9. doi: 10.1089/jwh.2011.2839. Epub 2011 Oct 19.
- Background: PubMed 12117397Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
- Individual participant dataSharing planned: No
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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.
Poli Mara Spritzer, PhD principal investigator
Federal University of Rio Grande do Sul, Porto Alegre, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hormone therapy (estradiol and micronized natural progesterone) and Non-oral hormone therapy (estradiol and micronized natural progesterone) in people with Menopause and Hormone Replacement Therapy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 9 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 Jul 2020. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayane M Fighera, PhD (+55 51 998004004, tfighera@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition parameters (time frame: Before hormone therapy and after 3 and 6 months of treatment). The study lists 2 primary outcomes in all. 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 NCT04453332, which also lists 10 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 1 Jul 2020.