A randomized, open-label, crossover study comparing the effects of oral versus transdermal estrogen therapy on serum androgens, thyroid hormones, and adrenal hormones in naturally menopausal women

Author(s):  
Jan L. Shifren ◽  
Sophie Desindes ◽  
Marilyn McIlwain ◽  
Gheorghe Doros ◽  
Norman A. Mazer
1990 ◽  
Vol 592 (1) ◽  
pp. 460-462
Author(s):  
F. PANSINI ◽  
C. M. BERGAMINI ◽  
G. BONACCORSI ◽  
P. BREVEGLIERI ◽  
M. CALISESI ◽  
...  

Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.


2017 ◽  
Vol 39 (1) ◽  
pp. 138-149 ◽  
Author(s):  
Ju-Hee Ryu ◽  
Joo-Il Kim ◽  
Hyung Son Kim ◽  
Gyu-Jeong Noh ◽  
Kyung-Tae Lee ◽  
...  

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