Action And Clinical Pharmacology
Mechanism of Action
ALESSE acts primarily through the mechanism of gonadotropin suppression due to estrogenic and progestational activity of their components, in a manner that inhibits ovulation, which leads to contraception. Some studies have demonstrated changes in the endometrium and cervical mucus with the use of hormonal contraceptives. However, further research is required to determine, quantitatively, whether or not the contribution of changes in endometrium and cervical mucus, observed with combination oral contraceptives, have a role in the prevention of pregnancy.
Acne is a disease of the pilosebaceous apparatus characterized by abnormal keratinization, increased sebum production, and bacterial colonization. While the etiology of acne is multifactorial, there is evidence that androgenic action, including stimulation of sebaceous glands, is necessary for the development of acne. The suppression of gonadotropins by ALESSE leads to decreased ovarian production of the androgens, including androstenedione. ALESSE also significantly reduces bioavailable serum testosterone by preserving the estrogen-induced increases in sex hormone binding globulin (SHBG).14, 30 In addition, ALESSE decreases serum levels of 3b-androstanediol glucuronide (a marker of peripheral 5 b-reductase activity).14,30 These biochemical changes produced by the coadministration of levonorgestrel and ethinyl estradiol are consistent with improvement of acne in otherwise healthy women.
Special Populations and Conditions
Geriatrics (> 65 years of age):
ALESSE is not indicated for use in postmenopausal women.
Pediatrics (< 16 years of age):
Safety and efficacy of ALESSE tablets have been established in women of reproductive age. Use of this product before menarche is not indicated.