Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new vivelle research articles will be listed here shortly after becoming available to us.
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Medical research on vivelle
J Biomed Mater Res B Appl Biomater. 2008 Jun 10;
Wokovich AM, Brown SA, Shen M, Doub WH, Cai B, Sadrieh N, Chen ML, Machado S, Buhse LF
In a previous study on peel adhesion for medical tapes, it was shown that a stainless steel (SS) substrate better discriminated among medical tapes than a high-density polyethylene (HDPE) substrate. The objective of this study was to determine if a SS substrate would also better distinguish among transdermal drug delivery systems (TDDSs). Five TDDSs (Vivelle Dot(R), Climara(R), Catapres-TTS(R), Duragesic(R), and Mylan Fentanyl) were evaluated on three different substrates (SS, HDPE, and human cadaver skin). All measurements were made using a dwell time of approximately 3 min, a peel angle of 90 degrees , and a peel speed of 300 mm/min. Differences among TDDSs were greater for SS than for HDPE, using the F statistic for testing for differences among TDDSs means as a measure of heterogeneity, thereby indicating greater discrimination by SS. (c) 2008 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2008.
OESCLIM: an advanced delivery system for HRT.
Maturitas. 1999 Nov; 33 Suppl 1: S39-47
Munoz A
AIMS: Transdermal estradiol offers a number of advantages over traditional oral routes of hormone replacement therapy (HRT) because it is not subject to the hepatic first-pass effect. However, transdermal systems need to balance adhesion, tolerability, and flux if they are to be effective. OESCLIM is a transdermal 17-beta estradiol HRT system designed to address the problems of conventional transdermal patches and offer optimal adhesion and tolerability in an effective HRT system. This paper reviews some of the data on OESCLIM with reference to its delivery system. RESULTS: The innovative technology used in OESCLIM results in a smooth pharmacokinetic profile throughout the 3-4 day application period. In recent pharmacokinetic studies, OESCLIM 50 provided a more consistent release of hormone than Estraderm TTS 50 and higher mean estradiol levels than Systen and Vivelle. This smooth pharmacokinetic profile is also maintained whether OESCLIM is attached to different body sites. The local skin tolerability of OESCLIM is good. One study reported that OESCLIM 50 caused less than half the number of skin reactions as Estraderm TTS 50 (4.2% compared to 9.5%). OESCLIM has also been shown to have fewer detachments than Estraderm TTS (6% compared to 11%). Both differences were statistically significant (P < 0.001). A study has shown OESCLIM to be as effective as Estraderm TTS at reducing vasomotor symptoms even in highly symptomatic women. CONCLUSION: OESCLIM is a very good first-line choice for estrogen replacement therapy (ERT) or HRT providing effective therapy with optimum adhesion, flux and tolerability profiles.
Am J Obstet Gynecol. 2000 Jan; 182(1 Pt 1): 7-12
Notelovitz M, Cassel D, Hille D, Furst KW, Dain MP, VandePol C, Skarinsky D
OBJECTIVE: This study was undertaken to evaluate the efficacy and tolerability of a combination estradiol plus norethindrone acetate transdermal delivery system given in a continuous sequential regimen with transdermal estradiol versus placebo in the treatment of vasomotor symptoms of menopause. STUDY DESIGN: This was a 12-week double-blind trial of 220 healthy postmenopausal women with > or = 8 moderate to severe hot flushes and sweating episodes per day. Women were randomly assigned to wear transdermal placebo patches or a transdermal patch releasing 50 microg/d 17beta-estradiol alone (Vivelle) for days 1 to 14 of each cycle and a combination patch releasing 50 microg/d 17beta-estradiol plus 1 of 3 dosage levels (140, 250, or 400 microg/d) of norethindrone acetate (CombiPatch) for days 15 through 28. RESULTS: There was a significant (P
Neurology. 1999; 53(4 Suppl 1): S29-33
Fettes I
Many women with migraine, especially those with a history of menstrual migraine, experience an exacerbation as they approach menopause. During this time, the orderly pattern of estrogen and progesterone secretion is lost. The fluctuating and falling levels of estrogen during the perimenopausal years may increase the frequency and severity of migraine. In such women, restoration and stabilization of estrogen levels within the physiologic range are likely to diminish the migraine. Although continuous combined hormone replacement therapy with estrogen and progesterone is becoming increasingly popular for postmenopausal women, many women are still prescribed cyclic replacement initially. For the woman who is susceptible to fluctuations in estrogen and progesterone, initiation of cyclic therapy after menopause may exacerbate migraine. This could occur in a woman who noted an improvement in migraine after menopause with complete cessation of menses and stable levels of estrogen. For the woman with migraine, continuous combined estrogen and progesterone (or estrogen alone, if the uterus has been removed) replacement is the preferred therapy. This can be achieved with a 50-microg/day estrogen skin patch such as Estraderm or Vivelle twice weekly or Climara once weekly, or with an oral estrogen such as Premarin, Ogen, or Estrace, with half the daily dose given every 12 hours to maintain optimal stability. In the presence of a uterus, progesterone should be added, either as low-dose medroxyprogesterone acetate (Provera) 2.5 mg every evening or micronized progesterone (Prometrium) 100 mg every evening. The usual contraindications to hormone replacement therapy may be applied to women with migraine.
J Clin Pharmacol. 1999 Aug; 39(8): 811-6
Guichard JP, Sauron R, Jones AB
Oesclim (Laboratoires Fournier, Dijon, France), also known as Esclim or Esclima, is a new estradiol transdermal delivery system (TDS) developed for the treatment of menopausal vasomotor symptoms. This open, randomized, three-way crossover study compared in 24 healthy postmenopausal women the pharmacokinetics of estradiol after a single 4-day application of Oesclim 50, Oesclim 100, and Vivelle 0.05 (CibaGeneva Pharmaceuticals, Summit, NJ; known as Menorest 50 in Europe, Rhône-Poulenc Rorer) on the upper buttock. Serum estradiol concentrations were determined by a validated radioimmunoassay method from samples taken before and during each TDS application. The concentration-time profiles for Vivelle 0.05 and Oesclim 50 were comparable with a similar absorption rate, giving a maximum concentration (Cmax) of 49 and 53 pg/mL above baseline, respectively, followed by a plateau throughout the 96-hour application period. At the end of this period, mean corrected estradiol concentrations were 18 and 19 pg/mL, respectively. The estradiol serum concentrations obtained after an application of Oesclim 100 were approximately twice as high than with Oesclim 50. All products were well tolerated, but skin intolerance was more frequent with Vivelle 0.05 (4 patients; four reports) and Oesclim 100 (3 patients; three reports) than with Oesclim 50 (none). Problems of imperfect adhesion were more than five times as frequent with Vivelle 0.05 (44%) than with Oesclim (8%).