Contraception
Volume 76, Issue 6 , Pages 432-438 , December 2007

An initial pharmacokinetic study with a Metered Dose Transdermal System® for delivery of the progestogen Nestorone® as a possible future contraceptive

  • Ian S. Fraser

      Affiliations

    • Department of Obstetrics and Gynaecology, University of Sydney, NSW 2006, Australia
    • Sydney Centre for Reproductive Health Research, Research Division of Family Planning NSW, Ashfield, NSW 2131, Australia
    • Corresponding Author InformationCorresponding author. Tel.: +61 2 9351 2478; fax: +61 2 9351 4560.
    • ,
  • Edith Weisberg

      Affiliations

    • Department of Obstetrics and Gynaecology, University of Sydney, NSW 2006, Australia
    • Sydney Centre for Reproductive Health Research, Research Division of Family Planning NSW, Ashfield, NSW 2131, Australia
    • ,
  • Narender Kumar

      Affiliations

    • Center for Biomedical Research, Population Council, Brooklyn, NY 10021, USA
    • ,
  • Sushma Kumar

      Affiliations

    • Center for Biomedical Research, Population Council, Brooklyn, NY 10021, USA
    • ,
  • Andrew J. Humberstone

      Affiliations

    • Acrux Ltd., West Melbourne, Vic 3003, Australia
    • ,
  • Louise McCrossin

      Affiliations

    • Acrux Ltd., West Melbourne, Vic 3003, Australia
    • ,
  • Deborah Shaw

      Affiliations

    • Centre for Pharmaceutical Research, University of South Australia, North Terrace, Adelaide, SA 5000, Australia
    • ,
  • Y.Y. Tsong

      Affiliations

    • Center for Biomedical Research, Population Council, Brooklyn, NY 10021, USA
    • ,
  • Regine Sitruk-Ware

      Affiliations

    • Center for Biomedical Research, Population Council, Brooklyn, NY 10021, USA

Received 6 August 2007 ,Revised 9 August 2007 ,Accepted 15 August 2007.

References 

  1. Samsioe G. Transdermal hormone therapy: gels and patches. Climacteric. 2004;7:347–356
  2. Urdl W, Apter D, Alperstein A, et al. Contraceptive efficacy, compliance and beyond: factors related to satisfaction with once-weekly transdermal compared with oral contraception. Eur J Obstet Gynecol Reprod Biol. 2005;121:202–210
  3. Kumar N, Koide SS, Tsong YY, Sundaram K. Nestorone®: a progestin with a unique pharmacological profile. Steroids. 2000;65:629–636
  4. Sitruk-Ware R. New progestagens for contraceptive use. Hum Reprod Update. 2006;12:169–178
  5. Sitruk-Ware R, Small M, Kumar N, Tsong YY, Sundaram K, Jackanicz T. Nestorone: clinical applications for contraception and HRT. Steroids. 2003;68:907–913
  6. Brache V, Mishell DR, Lahteenmaki P, et al. Ovarian function during use of vaginal rings delivering three different doses of Nestorone. Contraception. 2001;63:257–261
  7. Fraser IS, Weisberg E, Brache V, et al. Serum Nestorone and ethinyl estradiol levels, and ovulation inhibition in women using three different dosage combinations of a Nestorone progestogen–ethinyl estradiol contraceptive vaginal ring on a bleeding-signaled regimen. Contraception. 2005;72:40–45
  8. Croxatto HB, Zepeda A. Transdermal contraceptive systems: innovative technology for the twenty-first century. In:  Sitruk-Ware R,  Bardin W editor. Contraception. Newer pharmacological agents, devices, and delivery systems. New York: Marcel Dekker; 1992;p. 101–115
  9. Diaz S, Schiappacasse V, Pavez M, et al. Clinical trial with Nestorone™ subdermal contraceptive implants. Contraception. 1995;51:33–38
  10. Humberstone AJ, Evans AM, Nation RL, MacLennan AH. Comparison of pharmacokinetics and tolerability following application of an Estraderm® 50 patch or a novel Estradiol Metered-Dose Transdermal Spray (MDTS®). In: Presented as the North American Menopause Society 13th Annual Meeting. Chicago, IL, US. 2002;
  11. Humberstone AJ, Evans AM, Davis SR. A comparative study of the pharmacokinetics of testosterone (T) following administration of a Metered-Dose Transdermal Spray (MDTS) to the abdomen or forearm in healthy postmenopausal women with low serum testosterone. In: Presented at the Endocrine Society's 85th Annual Meeting, Philadelphia, PA, USA. 2003;
  12. Brache V, Massai R, Mishell DR, et al. Ovarian function during use of Nestorone® subdermal implants. Contraception. 2000;61:199–204
  13. Olsen CT. Evaluation of the dermal irritancy of chemicals. In:  Hobson DW editors. Dermal and ocular toxicology fundamentals and methods. Boca Raton, FL: CRC Press; 1991;p. 130–131
  14. Lahteenmaki P, Weiner E, Lahteenmaki P, et al. Contraception with subcutaneous capsules containing ST-1435 (Nestorone); pituitary and ovarian function and plasma levels of ST-1435. Contraception. 1981;23:63–75
  15. Heikinheimo O, Noe G, Haukkamaa M, Lahteenmaki P. The progestin ST-1435 — rapid metabolism in women. Contraception. 1994;50:275–289
  16. Wiseman LR, McTavish D. Transdermal estradiol/norethisterone. A review of its pharmacological properties and clinical use in postmenopausal women. Drugs Aging. 1994;4:238–256
  17. Abrams LS, Skee DM, Natarajan J, et al. Multiple-dose pharmacokinetics of a contraceptive patch in healthy women participants. Contraception. 2001;64:287–294

☆ Funding for this study was provided jointly by the Population Council and Acrux Ltd.

PII: S0010-7824(07)00409-X

doi: 10.1016/j.contraception.2007.08.006

Contraception
Volume 76, Issue 6 , Pages 432-438 , December 2007

Article Tools

* Image Usage & Resolution