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Monthly birth control patch – Expert Reaction

US researchers have developed a new reversible contraceptive microneedle patch that slowly releases the hormone levonorgestrel over the course of a month, according to a study published this morning in Science Advances.


They report microneedles containing the hormone transfer to the skin within one minute of contact, after which the patch can be thrown away, without needing to dispose of it in hazardous sharps waste like injection needles.

While the efficacy of the patch to deliver contraceptive over time has been demonstrated in rats, so far they have only tested if a placebo patch is safe for women. Further testing on the efficacy in humans will be needed before the patch can go to market.

The researchers tested the comfort and acceptability of using the patches in women in the United States, India, and Nigeria. They found the simple administration and opportunities for discreet self-application were appealing, with many saying they'd use the patch if it were available.

The SMC gathered expert comment on the study, feel free to use these comments in your reporting.

Professor Helen Paterson, University of Otago, Wellington, comments:

"This is an interesting development and we look forward to further information. Increasing contraceptive options will ensure more people are able to find their optimal choice. The use of monthly contraception has not previously shown improved efficacy. For example, the vaginal ring was not more efficacious than the oral pill.

"If efficacy is similar to implants - our most effective contraceptive - then this would be a positive addition to choices but it must be able to be dispensed in 6-monthly volumes as a minimum. Whilst an interesting development, it is unlikely to impact on intrauterine device use which work locally and have other benefits."

Conflict of interest statement: I am involved in contraceptive research. I have attended a conference in 2010 funded by Bayer. I also have worked with Bayer on research and training but not received any payment for this. I have a patent in contraceptive devices unrelated and with no crossover with this device.

Associate Professor Jingyuan Wen, School of Pharmacy, University of Auckland, comments:

"Microneedle technology is a relatively new and innovative technology in the field of drug delivery and there have been many studies showing its potential to revolutionise the manner of drug administration.

"This is a promising patient-friendly technique to ensure effective penetration of drugs into the skin in a minimally invasive manner by employing multiple micron-sized needles attached to a support.

"Microneedles also involve an effortless and simple application method, which makes them beneficial for long-term applications. There is also a reduced risk of needle-stick injuries and cross-contamination issues when using microneedles. Microneedles pierce the stratum corneum and create micro-channels, without distressing the nerve endings and blood vessels in the inner skin layers of epidermis and dermis.

"During the last few years, there has been a remarkable increase in the number of clinical studies (>50) related to the application of microneedle-based devices and the majority of them are focussed on vaccine delivery and treatment of skin disorders. Therefore, further clinical development is expected to validate the efficacy of this technology.

"However, the safety aspects should be carefully investigated while designing and developing microneedle-based drug delivery systems as they are not equivalent to the conventional transdermal patches, which are just applied on to the skin surface. Microneedles puncture and penetrate the defensive layer of skin and therefore it is obligatory for the products to be entirely devoid of microorganisms which can lead to local and systemic toxicities.

"The paper by Li et al. presents a very interesting approach utilising effervescence-based microneedles, for the first time, to deliver long-acting contraceptives. They have demonstrated that the effervescent microneedle patch made using biodegradable polymer, can effectively provide contraception for more than a month, which is interesting. The study also evaluated and revealed overwhelming acceptability of the microneedle patches for long-acting contraception among women of reproductive age in the United States, India, and Nigeria. This approach will greatly improve the access to contraceptives and provide better patient compliance by overcoming the limitations associated with the conventional contraceptive options."

No conflict of interest.

Our colleagues at the Australian Science Media Centre also gathered comments on the study. Feel free to use these comments in your reporting.

Dr Gino Pecoraro, Associate Professor of obstetrics and gynaecology, University of Queensland, comments:

"More than 50% of spontaneous pregnancies in Australia are unplanned. So many in fact, that doctor groups like the AMA frequently call for pregnancy to treated as 'an accident' in private insurance policies and offer cover in all policies, rather than having pregnancy excluded from all but top level insurance policies.

"Apart from social, economic and emotional upheaval, unwanted pregnancies can result in women needing termination of pregnancy which according to provider statistics (Children by Choice) run at 15-20 per 1000 Australian women, and is considered high by international standards.

"Prevention of an unwanted pregnancy is the very much preferred alternative and novel safe, effective and easy to use methods of contraception are always welcomed. Compared to other nations, Australia has an increased reliance on oral contraceptives (and barrier methods like condoms), which although effective if used correctly, can cause side effects, inconvenience and require women to be compliant with their daily administration.

"The World Health Organisation (WHO) is on the record as saying Australian women should be using more Long-Acting Reversible Contraceptives (LARC’s) like implants, injections or intrauterine devices, which are associated with fewer method failures from compliance and result in less unwanted pregnancy.

"This study looks at a promising new drug delivery system for a progesterone only contraceptive which has significant implications for a whole range of other drugs.

"Progesterone only contraceptives have advantages for some women, especially those needing to avoid added oestrogen. In addition, non-oral administration of the hormone can also provide specific benefits in some women.

"The 'effervescent microneedle patch' technology described in this research, is a special delivery system whereby microneedles containing Levonorgestrel (an artificial progesterone hormone already in use as a contraceptive) are embedded in a small skin patch which is applied by the woman to her skin.

"After 50 seconds, a chemical reaction causes the microneedles to be released from the patch and painlessly insert into the skin where they start slowly dissolving and release the active ingredient. The patch can then be discarded and not does contain any sharps or biologically active agents, dispensing with the need for specific biological waste containers.

"Animal and human recipients were studied and no significant adverse effects were reported. Skin redness usually disappeared within an hour and pain if present at all, was much less than that experienced with an injection.

"Patient acceptability across multiple continents was high and women reported liking the idea of self-administration of LARC’s without need for doctor visits, invasive injections, implants or IUD insertions. A number reported preference for longer acting (3 or 6 month patches) and this needs further study as does contraceptive efficacy and cost.

"Transdermal delivery of drugs is a rapidly growing area and the use of microneedle technology rather than traditional adhesive based patches offers a number of advantages especially in hot and humid countries like ours where patches can slip or fall off and adhesives can irritate.

"If successful, this delivery system can be expanded for many more drugs (not just hormones) and is certainly worthy of further development."

Conflict of interest statement: I wish to declare that I provide advice to a number of drug companies in the area of contraception, both oral contraceptives and LARC’s and have published on thrombosis side effects of oral contraceptives but don’t believe that this is a conflict. I’m also chair of federal AMA board and a national councillor for National Association of Specialist Obstetricians and Gynaecologists (NASOG).

Dr Alex Polyakov, Clinical Director, Melbourne IVF at Royal Women’s Hospital, and Clinical Senior Lecturer, University of Melbourne, comments:

"This study describes a novel approach to administering a contraceptive agent via a one-minute application of a skin patch. The authors used Levonogestrel for this study as the active agent responsible for the contraceptive effect. This is the same compound that is used in some oral contraceptive pills, implants, patches and intrauterine devices such as Mirena. As stated by the authors, Levonogestrel has been used in various preparations for contraception for a number of years since 1960’s, has an excellent safety record and well-studied pharmacokinetic and pharmacodynamic profile.

"The current study combined a number of research projects which included testing the contraceptive patch on mice, testing placebo patches on human volunteers and interviews with women regarding acceptability and desirability of yet another contraceptive option.

"The proposed application of the microneedle patch technology described in the article would consist of a one-minute contact of the patch with the skin, applying some pressure on the patch. In that time microneedles containing Levonogestrel will be deployed under the skin. These microneedles will slowly be reabsorbed by the women’s bodies and due to its gradual reabsorption, Levonogestrel will slowly be released into the bloodstream over a period of time (authors studied monthly patches).

"The advantages of this contraceptive method are the ease of self-administration, safety and effectiveness, possible low cost and full reversibility.

"It must be pointed out that the authors did not invent a new contraceptive drug, but rather used a very old one in a novel application device. While Levonogestrel has a very good safety and effectiveness record, it has certain side-effects that are also well recognised and which are likely to be unaffected by the new administration process. Two of the most bothersome side-effects of Levonogestrel-containing long term contraceptives are irregular bleeding and undesired psychological effects. These are not addressed by the paper.

"This study can only be considered an initial step in developing a novel option to administer Levonogestrel for contraceptive purposes. The active patch was not administered to human participants, who were only tested with placebo patches. The pharmacological profile of the device was only tested in mice and may not to be completely translatable to humans. Interviews with women regarding acceptability and desirability of such contraceptive patch being available did not include questions on costs and possible side-effects. Further research is clearly required in order to ensure that this patch microneedle technology is safe and effective in humans.

"One must also be mindful of further significant research effort that is required to gain regulatory approval in various countries such as FDA in the USA and TGA in Australia, I would anticipate that it will be between 5 and 7 years before the patch is available to be used by the general public."

No conflict of interest.

Professor Rachel Skinner, Deputy Director of WH&Y and professor in the Faculty of Medicine and Health at the University of Sydney, comments:

“Microneedle patches are an exciting and promising way of improving access to common and important medications that are usually administered by needle or tablet.

Microneedle patches have promising benefits over traditional methods of administration: they are very simple and safe to administer and self-administration may be possible, with simple instructions. They are likely to be cost-effective if they remove the need for expensive medical procedures.

In this study we see the potential of a microneedle patch for long-acting reversible contraception. The authors show data in rats that the microneedle patch maintained protective levels of a common and highly effective contraceptive for more than a month. They also showed that the mechanism of the dissolving microneedle patch also worked in human skin. They also showed that a small sample of women indicated that they would prefer to use contraception administered by microneedle patch than by needle or by daily tablet.

If this technology is shown to work in humans, it has the potential to improve access to effective contraception, due to the simplicity of use. This is especially important for young women and women in low-income countries where cost and access to services are challenges to contraception access.”

No conflict of interest declared.


ends

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