TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS (THRT)
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|ClinicalTrials.gov Identifier: NCT02033512|
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Menopause||Drug: Transdermal Hormone Replacement Therapy Drug: Transdermal Nanoformulation Drug: Transdermal formulation||Phase 2|
This was a prospective long-term clinical trial study of female patients aged 51-70 years old treated for menopause related hormone imbalances. Other results of this study are published elsewhere. Volunteers were recruited from referenced Gynecological Medical service where patient charts are maintained.
This study is a prospective long-term clinical trial study randomized trial assessing the effects of Transdermal HRT on climacteric symptoms and hormone serum levels in early postmenopausal women. Preliminary results of this trial, including the first 42 women enrolled, have been published (3).
In the present analysis, 66 women received daily in the right and left forearms a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The following were compared: effects of transdermal gel on baseline and after THRT were also analyzed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NANOSTRUCTURED TRANSDERMAL HORMONE REPLACEMENT THERAPY RELIEVING MENOPAUSAL SYMPTOMS: A CONFOCAL RAMAN SPECTROSCOPY STUDY|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||April 2008|
- Drug: Transdermal Hormone Replacement Therapy
The Blood samples were 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 progesterone was prescribed. The patients were evaluated 3 months after THRT treatment protocol.
All the patients were instructed about how to use the progesterone pump for transdermal application, 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.Other Name: Biolipideo/B2®
- Drug: Transdermal Nanoformulation
The Blood samples were 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 hormones were prescribed.Other Name: Biolipid/B2, Biolipideo/B2, Evidence Soluções Farmaêuticas
- Drug: Transdermal formulation
66 patients completed the study. In the present analysis, the subjects received daily in the right and left forearm a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The effects of transdermal hormone formulation were analyzed.Other Name: Biolipid/B2®
- Estradiol Levels [ Time Frame: 5 years ]
Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on Estradiol serum levels
The serum levels of estradiol, over the 60 months of THRT are shown in Figure 8. Statistical analysis of mean Estradiol pretreatment values at baseline was 28.88 ± 39.62 (pg/mL) and after 60 months of THRT showed a significant increase to 51.85 ± 77.50. The data reached a statistical difference (p<0.05) after the treatment with the transdermal formulation.
- Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on postmenopausal complaints [ Time Frame: 5 years ]The postmenopausal symptomatology analysis of the volunteers subjected to THRT that received the nanoformulation revealed a significant decreasing of postmenopausal scores complaints (Figure 3). These values were statistically significant (P < 0.05), when the mean values from baseline were compared after 60 months of treatment. The extent of satisfaction with the hormone therapy was ~75%. The continuation induced further increases in the extent of satisfaction: 85.2 after one year and 92.5 ± 4.2% at the end of study (P < 0.05).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033512
|Fortaleza, CE, Brazil, 60115-191|
|Principal Investigator:||MARCO A BOTELHO, PhD||University Potiguar|
|Study Chair:||Dinalva B Queiroz, MsC||School of Health|