OESCLIM: pre-clinical and clinical profile.
BACKGROUND
The majority of women will suffer some form of vasomotor symptoms at the menopause. Hormone replacement therapy (HRT) has been shown to reduce the incidence of these symptoms although compliance with HRT is still poor. OESCLIM is a transdermal estrogen-replacement therapy for the treatment of estrogen deficiency.


METHODS
In this paper, the main pre-clinical and clinical data relating to OESCLIM are reviewed.


RESULTS
OESCLIM has a stable pharmacokinetic profile over the treatment period of 3-4 days and has been shown to have advanced pharmacokinetics when compared to other leading transdermal systems. It has been shown to reduce vasomotor symptoms by 94% in post-menopausal women, with near maximal reduction in symptoms after 4 weeks of treatment. In highly symptomatic women, low dose (25 microg/day) OESCLIM therapy resulted in a statistically significant reduction in symptoms compared to placebo from week 3. OESCLIM also has good local skin tolerability, and is significantly better tolerated than Estraderm TTS 50. It is also well accepted among patients. In long-term studies, 79.8% of patients wished to continue OESCLIM therapy at the end of a 3-year study.


CONCLUSIONS
OESCLIM is an innovative first-line transdermal estrogen-replacement therapy with good efficacy and tolerability. The ability to initiate treatment at a low dose (25 microg/day) may have advantages for the patient starting therapy by reducing symptoms of hyperestrogenism whilst allowing for dose titration upwards if necessary.
Guy
M
M
Laboratoires Fournier, Daix, France.
D000279:Administration, Cutaneous; D002979:Climacteric; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods; D005260:Female; D019584:Hot Flashes; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance
D004958:Estradiol