Menopausal SyndromePhase 2NanoparticleNCT02467673
Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy
A Phase 2 study testing Micronized estradiol + progesterone and Nanoparticulate estradiol + progesterone in people with Menopausal Syndrome, run by University Potiguar at 3 sites in Brazil.
Trial summary
The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO) transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein (CRP), and cardiovascular risk factors in postmenopausal women. Read more about this study
- Who is it for?
- Ages 42 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Syndrome
- What is being tested?
- Micronized estradiol + progesterone and Nanoparticulate estradiol + progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2012to Jul 2012
- Phase
- Phase 2
- 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 42 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A body mass index between 18 and 27 kg/m2;
- Sex live complaints;
- No evidence of cardiovascular disease;
- General good health based on history and physical examination.
Who cannot join
- A past history of neurological disorder;
- Had received pharmacotherapy for cardiovascular disease before screening
- Taking medication known to interfere with steroids;
- Recent psychiatric or systemic illness;
- Uncontrolled hypertension (blood pressure>160/95mmHg),
- Unstable cardiovascular disease;
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- Genital bleeding;
- Use of psychoactive medications,
- Alcohol excess consumption or any other drug abuse;
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Gynelogical Center
Fortaleza, Ceará, 60115-191
University Potiguar
Natal, Rio Grande do Norte, 59060
Marco Botelho
São Paulo, São Paulo, 04023-062
About this study
Official title: Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy: Effects on Blood Pressure, Insulin and C-reactive Protein and in Postmenopausal Women
The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO) transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein (CRP), and cardiovascular risk factors in postmenopausal women.
Read the detailed description
In this open label study, 27 postmenopausal women, with no clinical evidence of cardiovascular disease, were randomly divided in two groups.
During 12 weeks,
15 patients received on the left forearm micronized (MIC) THT (micronized 17β-estradiol 2.5 mg/day + progesterone 100 mg/day).
and
14 patients received a nanoparticulate (NANO) THT (nanoparticulate 17β-estradiol 2.5 mg/day + progesterone 100mg/day).
After 12 weeks of treatment patients were evaluated.
Baseline and Post-THT measures were determined: Insulin, body mass index, waist circumference, blood pressure, CRP-stratified levels, total testosterone, TSH and FSH levels.
- Conditions
- Menopausal Syndrome
- Being tested
- Micronized estradiol + progesterone, Nanoparticulate estradiol + progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized estradiol + progesteroneDrug
Also called Mic Group
Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
Nanoparticulate estradiol + progesteroneDrug
Also called NANO Group
Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
| Study group | Role | What they receive |
|---|---|---|
| NANOPARTICULATE estradiol+ progesterone | Active comparator | The Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal nanostructured estradiol and progesterone is prescribed.
The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications. Receives: Drug: Nanoparticulate estradiol + progesterone |
| MICRONIZED estradiol+ progesterone | Active comparator | The Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal micronized estradiol and progesterone is prescribed.
The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications. Receives: Drug: Micronized estradiol + progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure variation
Measured: 12 weeks
Secondary outcomes (1)
C-reactive protein levels after treatment
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 posted10 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menopausal SyndromeStudies 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
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Potiguar
- Sponsor type
- University, hospital or other
- Collaborators
- InBios International, Inc., Federal University of São Paulo
- Responsible party
- Principal investigator, MARCO BOTELHO, University Potiguar
- Investigators
- Ivaldo Silva, PHD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467673
- Sponsor's protocol ID
- Evidence/Unifesp
- Acronym
- Nanoparticle
- Status last verified
- May 2016
- First submitted
- 7 Jun 2015
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003.
PubMed 20835566Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.
PubMed 24519196
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy: Effects on Blood Pressure, Insulin and C-reactive Protein and in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02467673
- Acronym / sponsor ID
- Nanoparticle / Evidence/Unifesp
- Conditions
- Menopausal Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University PotiguarUniversity, hospital or other
- Collaborators
- InBios International, Inc., Federal University of São Paulo
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Jun 2015 (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.
The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO) transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein (CRP), and cardiovascular risk factors in postmenopausal women.
Detailed description
In this open label study, 27 postmenopausal women, with no clinical evidence of cardiovascular disease, were randomly divided in two groups.
During 12 weeks,
15 patients received on the left forearm micronized (MIC) THT (micronized 17β-estradiol 2.5 mg/day + progesterone 100 mg/day).
and
14 patients received a nanoparticulate (NANO) THT (nanoparticulate 17β-estradiol 2.5 mg/day + progesterone 100mg/day).
After 12 weeks of treatment patients were evaluated.
Baseline and Post-THT measures were determined: Insulin, body mass index, waist circumference, blood pressure, CRP-stratified levels, total testosterone, TSH and FSH levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NANOPARTICULATE estradiol+ progesterone | Active comparator | Drug: Nanoparticulate estradiol + progesteroneThe Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal nanostructured estradiol and progesterone is prescribed. The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications. |
| MICRONIZED estradiol+ progesterone | Active comparator | Drug: Micronized estradiol + progesteroneThe Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal micronized estradiol and progesterone is prescribed. The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications. |
Who may qualify
- Ages
- 42 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A body mass index between 18 and 27 kg/m2;
- Sex live complaints;
- No evidence of cardiovascular disease;
- General good health based on history and physical examination.
Key exclusion criteria (9 listed)
- A past history of neurological disorder;
- Had received pharmacotherapy for cardiovascular disease before screening
- Taking medication known to interfere with steroids;
- Recent psychiatric or systemic illness;
- Uncontrolled hypertension (blood pressure>160/95mmHg),
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 |
|---|---|---|
| Micronized estradiol + progesteroneAlso: Mic GroupAdministration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease. | Drug | MICRONIZED estradiol+ progesterone |
| Nanoparticulate estradiol + progesteroneAlso: NANO GroupAdministration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease. | Drug | NANOPARTICULATE estradiol+ progesterone |
Primary outcome
Blood Pressure variation
Time frame: 12 weeks
1 secondary outcome
C-reactive protein levels after treatment
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 24 May 2016.
- Background: PubMed 20835566Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003.
- Results publication: PubMed 24519196Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.
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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.
Ivaldo Silva, PHD study director
Federal University of São Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micronized estradiol + progesterone and Nanoparticulate estradiol + progesterone in people with Menopausal Syndrome, run by University Potiguar at 3 sites 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: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
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?
Blood Pressure variation (time frame: 12 weeks). 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 NCT02467673, which also lists 2 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 24 May 2016.