By Rebecca Bowers

EXECUTIVE SUMMARY

Scientists are looking at administering contraceptive hormones through special jewelry backings to improve user compliance.

  • The jewelry consists of three layers. One layer is impermeable, with an adhesive to secure it to an earring back, the underside of a wristwatch, or the inside surface of a necklace or ring. The middle layer consists of the contraceptive drug levonorgestrel in solid form, while the outer layer is a skin adhesive designed to help stick to skin to facilitate drug transfer.
  • The first contraceptive patch, Ortho Evra, debuted in 2002 and ceased production in 2014. Its generic equivalent, Xulane, has been available since 2014.

Scientists are now looking at administering contraceptive hormones through special jewelry backings on items such as earrings, necklaces, and watches to improve user compliance.1

Despite the widespread use of birth control, about half of all pregnancies in the United States are unintended.2 Almost 90% of these are due to contraceptive failure, including imperfect use.3 By offering more contraceptive options, it is more likely that the needs of individual women can be met, says Mark Prausnitz, PhD, a Regents Professor and the J. Erskine Love Jr. chair in the School of Chemical and Biomolecular Engineering at the Georgia Institute of Technology. Prausnitz, Mohammad Mofidfar, PhD, postdoctoral fellow, and Laura O’Farrell, DVM, PhD, senior research scientist, have tested the contraceptive jewelry concept on animal models as an initial step in developing options for women. The proof-of-concept research was supported by the U.S. Agency for International Development under a subcontract funded by FHI 360.

“Because putting on jewelry may already be part of a woman’s daily routine, this technique may facilitate compliance with the drug regimen,” said Praunitz in a press statement. “This technique could more effectively empower some women to prevent unintended pregnancies.”

The earring patch tested by the Georgia Tech researchers is made of three layers. One layer is impermeable, with an adhesive to secure it to an earring back, the underside of a wristwatch, or the inside surface of a necklace or ring. The middle layer of the patch consists of the contraceptive drug levonorgestrel in solid form, while the outer layer is a skin adhesive designed to help stick to skin to facilitate drug transfer. Once the drug is absorbed by the skin, it moves into the bloodstream. Initial testing suggests the contraceptive jewelry may deliver sufficient amounts of hormone to provide contraception.1

The contraceptive jewelry has been tested on pigs’ ears and on the skin of hairless rats. To simulate removal of earrings during sleep, the researchers applied the patches for 16 hours, then removed them for eight hours. Results indicate that although drug levels dropped while the earrings were removed, the patch could produce necessary amounts of the hormone in the bloodstream.1

“Pharmaceutical jewelry introduces a novel delivery method that may make taking contraceptives more appealing,” states Praunitz. “Making it more appealing should make it easier to remember to use it.”

Taking Transdermal Contraception to New Levels

U.S. women may already be familiar with transdermal contraception: The first contraceptive patch, Ortho Evra, debuted in 2002. Mylan Inc. of Pittsburgh announced in April 2014 that it had received regulatory approval to market a generic version of the patch. The generic patch, trademarked as Xulane, delivers 150 mcg of norelgestromin and 35 mcg of ethinyl estradiol in a daily dose through the transdermal system, which is the same formulation as in the Ortho Evra patch. Janssen Pharmaceuticals decided to discontinue production of Ortho Evra about the time of the generic product rollout.

National prescription numbers for Ortho Evra decreased from 5 million in 2006 to about 1.3 million in 2010. Use of the patch may have decreased because of concerns about its use and risk of venous thromboembolism (VTE). In 2005 and 2008, the drug labeling was edited to address issues related to VTE risk with exposure to contraceptive hormones seen with Ortho Evra compared to certain combined oral contraceptives. In March 2011, the drug’s warning label was edited to include information on the potential risk of VTE and the pharmacokinetics profile of ethinyl estradiol associated with the use of Ortho Evra, which made the information more prominent to healthcare providers.

Agile Therapeutics is developing an investigational low-dose, once-weekly contraceptive patch called Twirla (AG200-15 levonorgestrel/ethinyl estradiol transdermal system). The patch is a combined hormonal contraceptive containing ethinyl estradiol and levonorgestrel. It is designed for application once weekly for three weeks, followed by a week without a patch. Research indicates the efficacy and safety of the Twirla patch are comparable to those of a combined pill.4 The patch has undergone additional comparative wear testing intended to assist with meeting regulatory approval.

Agile Therapeutics also is pursuing other forms of transdermal contraception, including a regimen designed to allow women to experience shorter, lighter periods; one to allow women to extend the length of their cycles; one that allows extension of the cycle length and shorter, lighter periods; and a progestin-only patch designed for use by women who cannot or do not wish to use estrogen.

REFERENCES

  1. Mofidfar M, O’Farrell L, Prausnitz MR. Pharmaceutical jewelry: Earring patch for transdermal delivery of contraceptive hormone. J Control Release 2019;301:140-145.
  2. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med 2016;374:843-852.
  3. Sonfield A, Hasstedt K, Gold RB. Moving Forward: Family Planning in the Era of Health Reform. New York, NY: Guttmacher Institute; 2014.
  4. Kaunitz AM, Portman D, Westhoff CL, et al. Low-dose levonorgestrel and ethinyl estradiol patch and pill: A randomized controlled trial. Obstet Gynecol 2014;123(2 Pt 1):295-303.