TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS

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Přihlášení Registrace

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PostaveníDokončeno

Sponzoři

University Potiguar

Spolupracovníci

Universidade Federal de Sergipe

KLINICKÉ HODNOCENÍ: NCT02033512

BioSeek: nct02033512

Klíčová slova

Abstraktní

There is a dilemma and a permanent debate about side effects on drugs administered orally. The first-pass metabolism is related with many side effects, since the metabolites of these compounds affect the course of human physiology. Conventional hormone therapy by oral route has been used for relieving menopausal symptoms. Transdermal estrogens have not been used extensively in Brazilian women with menopausal symptomatology, however; recently a previous long term study has indicated no increased risk breast cancer or vasomotor disorders in menopausal women, using transdermal HRT.

Popis

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.

Termíny

Poslední ověření:	12/31/2013
První předloženo:	12/09/2013
Odhadovaná registrace vložena:	01/08/2014
První zveřejnění:	01/09/2014
Poslední aktualizace byla odeslána:	01/08/2014
Poslední aktualizace zveřejněna:	01/09/2014
Aktuální datum zahájení studie:	12/31/2002
Odhadované datum dokončení primární:	12/31/2003
Odhadované datum dokončení studie:	03/31/2008

Stav nebo nemoc

Menopause

Intervence / léčba

Drug: Transdermal Hormone Replacement Therapy

Drug: Transdermal Nanoformulation

Drug: Transdermal formulation

Fáze

Fáze 2

Kritéria způsobilosti

Věky způsobilé ke studiu	51 Years Na 51 Years
Pohlaví způsobilá ke studiu	Female
Přijímá zdravé dobrovolníky	Ano
Kritéria	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.

Výsledek

Primární výsledná opatření

1. Estradiol Levels [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.

Měření sekundárních výsledků

1. Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on postmenopausal complaints [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).

TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS

Klíčová slova

progesterone

karcinom prsu

rakovina

estriol