Beneficios no anticonceptivos de 0, 02 mg de etinilestradiol/2 mg de acetato de clormadinona administrados en un régimen de 24+4 días / Non-contraceptive benefits of 0.02 mg ethinylestradiol /2 mg chlormadinone acetate in a 24 +4 days intake regimen

Objetivo: Demostrar la influencia sobre las molestias emocionales y físicas (beneficios no anticonceptivos) experimentadas durante el primer año de uso de un anticonceptivo oral combinado (AOC) que contiene 0,02 mg de etinilestradiol (EE) y 2 mg de acetato de clormadinona (ACM) administrado en un régimen de 24 + 4 días de placebo. Diseño del estudio: Análisis adicional de las sensaciones subjetivas registradas en los diarios de 1665 participantes de un estudio de Fase III multicéntrico, no controlado, de administración múltiple, después de 13 ciclos de EE/ACM en un régimen de administración de 24 + 4 días, publicado previamente. Resultados: Se informó de menor frecuencia de molestias emocionales y físicas en el ciclo de medicación 13 en comparación con los datos en la admisión y en el ciclo 1. La incidencia de ánimo depresivo se redujo en 84,5 por ciento y 72,2 por ciento respectivamente, y la irritabilidad en 87,3 por ciento y 66,0 por ciento. Las cefaleas se redujeron en 75,5 por ciento y 74,7 por ciento, las molestias mamarias en 77,1 por ciento y 66,1 por ciento, y la dismenorrea preexistente en 77,9 por ciento y 67,6 por ciento respectivamente. El abandono prematuro del estudio a causa de las molestias fue marginal, y el perfil del sangrado fue aceptable. Conclusiones: Un AOC de baja dosis que contiene 0,02 mg de EE + 2 mg de ACM, administrado en un régimen de 24 + 4 días, reduce significativamente la mayor parte de las molestias emocionales y físicas que se presentan durante los ciclos espontáneos de las mujeres, y se combina con un adecuado perfil de sangrado.

Objective: To demonstrate the influence on physical and psychological complaints during the first year of intake of the combined oral contraceptive (COC) 0.02 mg ethinylestradiol (EE)/2 mg chlormadinone acetate (CMA), administered in a regimen of 24 days of CMA/EE intake followed by 4 days of placebo intake. Study design: The subjective feelings of non-contraceptive benefits registered in women's diaries of 1,665 subjects participating in a multicentre, uncontrolled, multiadministration, Phase III trial, published elsewhere, were analyzed post-hoc after 13 cycles intake of EE/CMA in a 24 +4 days intake regimen. Results: Emotional complaints were reported less frequently at medication cycle 13 compared with admission and cycle 1. Depressive mood was reduced by 84.5 percent and 72.2 percent, irritability by 87.3 percent and 66.0 percent; physical complaints were also reduced: headaches by 75.5 percent and 74.7 percent, breast discomfort by 77.1 percent and 66.1 percent; pre-existing dysmenorrhea by 77.9 percent and 67.6 percent. Premature termination due to complaints was only marginal, the bleeding profile was accepted. Conclusions: The low-dose COC, 0.02 mg EE/2 mg CMA, administered in a 24 +4 day regimen, reduces significantly most of the emotional and physical complaints occurring during spontaneous cycles of women, combined with an adequate bleeding profile.

The Influence of Chlormadinone Acetate on the Total and Free Serum Prostate Specific Antigen Levels in Men with Benign Prostatic Hyperplasia / 대한비뇨기과학회지

PURPOSE: Chlormadinone acetate (CMA) therapy for benign prostatic hyperplasia (BPH) may lower the serum prostate specific antigen (PSA) level. However, little is known about the effect of CMA on the total or free serum PSA levels of PSA. Such information would be important since PSA testing is useful for prostate cancer screening. Thus, we prospectively studied the effect of CMA therapy on the total and free serum PSA levels. MATERIALS AND METHODS: The patients with lower urinary tract symptoms (LUTS) and BPH who were aged over 50 years were treated with 50mg CMA for 6 months. Men with a PSA level greater than 10ng/ml were excluded to reduce the likelihood of including cases of occult prostate cancer. Those with suspicious findings on the digital rectal examination and serum PSA testing were biopsied to rule out prostate cancer. alpha- blocking agents were permitted to treat the men with LUTS. Serum levels of the total and free PSA were measured at the study baseline and after approximately 3 and 6 months. The prostate volume (PV) was assessed by transrectal ultrasonography. RESULTS: The analysis included 170 patients with a mean age of 67.9 years, a baseline PV of 47.3ml and a baseline total PSA of 4.1ng/ml. The total PSA levels declined from 4.1ng/ml at baseline to 2.0ng/ml after 6 months of treatment (50.7% decrease, p<0.01). The mean percent free PSA (21% to 22% at baseline) was not significantly altered by CMA treatment. The PSA levels and PV at baseline did not affect the rate of decline of PSA. CONCLUSIONS: The total PSA serum levels decreased by an average of 50% during CMA therapy, but the percent free PSA did not change significantly. This information is potentially useful in the interpretation of the PSA data that's used for early detection of prostate cancer in the men receiving CMA.

Effect of Chlormadinone acetate(Prostal / 대한비뇨기과학회지

Based on the theory that benign prostatic hypertrophy may be induced by androgenic effect of testosterone derivatives, especially 5-alpha - dihydrotestosterone, on prostatic tissue, Chlormadinone acetate(CMA), potent oral synthetic antiandrogen was investigated in the treatment of benign prostatic hypertrophy. Twenty-two patients of prostatic hypertrophy were studied over six months period with a special reference to uroflowmetry and following results were obtained : 1) Chlormadinone acetate induced improvement of obstructive urinary symptoms in terms of uroflowmetric measurement. 2) It is very worthwhile to initiate medical treatment before undergoing any surgical intervention or when surgery is contraindicated.