TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
Paskutinį kartą patikrinta: | 12/31/2013 |
Pirmasis pateikimas: | 12/09/2013 |
Numatytas registravimas pateiktas: | 01/08/2014 |
Pirmas paskelbtas: | 01/09/2014 |
Paskutinis atnaujinimas pateiktas: | 01/08/2014 |
Paskutinis atnaujinimas paskelbtas: | 01/09/2014 |
Faktinė studijų pradžios data: | 12/31/2002 |
Numatoma pirminio užbaigimo data: | 12/31/2003 |
Numatoma studijų užbaigimo data: | 03/31/2008 |
Būklė ar liga
Intervencija / gydymas
Drug: Transdermal Hormone Replacement Therapy
Drug: Transdermal Nanoformulation
Drug: Transdermal formulation
Fazė
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 51 Years Į 51 Years |
Tinkamos studijoms lytys | Female |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - 1) last menstrual period between 6 months and 3 years before the beginning of the study plus follicle-stimulating hormone (FSH) levels higher than 35 IU/L; 2) age between 51 and 70 years; 3) no use of any medication known to interfere with hormonal levels in the past 6 months. Exclusion Criteria: - Patients presenting diabetes, previous hysterectomy, endometrial thickness higher than 5 mm, history of cancer, thromboembolism or established cardio vascular disease were excluded. |
Rezultatas
Pirminės rezultatų priemonės
1. Estradiol Levels [5 years]
Antrinės rezultatų priemonės
1. Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on postmenopausal complaints [5 years]