User Profiles on Transdermal Contraceptive Treatment - European Medical Journal
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User Profiles on Transdermal Contraceptive Treatment

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Reproductive Health
10 Mins

Authors: Artur J. Jakimiuk,1,2 Hanna Błaszczyk,2 Tomasz Oleksik2

1. Center for Reproductive Health, Institute of Mother and Child, Warsaw, Poland
2. Department of Obstetrics and Gynecology, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland

Disclosure: This blog has been sponsored, commissioned, and paid for by Gedeon Richter. The company has reviewed the content for factual accuracy and compliance purposes.

Prevention of pregnancy remains an important part of medical practice. Contraception can be used at many stages of the basic biological reproductive process and with a variety of contraceptive products. Contraceptive products are categorised by hormone content and method of action. Hormonal options include oral contraceptive (OC) pills, birth control patches, implants, injections, vaginal devices, and intrauterine devices. All products and methods are associated with benefits and potential complications that must be considered as patients and healthcare providers choose the most satisfying option.1-3

Transdermal contraception offers a well-tolerated, effective, reversible, and easy-to-use method of hormonal contraception with an increased likelihood of compliance relative to OCs. There is also less variability in plasma concentrations of oestrogen than with OCs, which may decrease oestrogen-related side effects that result from high peak oestrogen levels, such as nausea.4

The efficacy of the transdermal contraceptive patch has been evaluated in three clinical trials: a noncomparative trial and two randomised clinical trials comparing the patch to an OC. The data indicate that users of the transdermal contraceptive patch achieved perfect compliance in 88% of cycles compared with about 78% of cycles for OC users. Additionally, OC users who were in younger age groups had lower perfect compliance rates. For example, for OC users less than 20 years and aged 20–24 years, the compliance rates were 68% and 74%, respectively. Patient satisfaction was due to the simple application method at weekly intervals.5

The authors would like to present three cases of patients who, on the basis of their medical history and specific indications, were treated with transdermal contraception (Evra [norelgestromin/ethinyl estradiol]), and then discuss the benefits of such treatment.

Evra is a transdermal contraceptive system (referred to as ‘the patch’) that delivers ethinyl estradiol and 17-deacetyl norgestimate, the primary active metabolite of norgestimate. This patch is designed to deliver effective steady-state levels of the two hormones during the 7-day period of use (per patch).6-8

CASE ONE

An 18-year-old gravida (G) 0 female presented to a private clinic desiring information about contraceptive methods. Although they had never had any penetrative vaginal intercourse, the patient sought a reliable contraception as they considered sexual initiation with their boyfriend. The patient had their menarche at 13 years old and their menstrual bleedings became regular after about 2 years. They did not report any unscheduled bleedings, but their periods tended to be moderately painful. Their additional health problem is cystic acne. The patient’s hormonal testing excluded hyperandrogenism as an underlying cause, but as the topic treatment was ineffective their dermatologist put them on isotretinoin oral therapy. Therefore, the patient had been informed that they needed an effective, stable, and preferably easy-to-use contraceptive method. Otherwise, their medical history was unremarkable, they had never had any surgical interventions, and their BMI was within normal range. The patient had no history of thromboembolism and denied smoking. They had never had a Pap smear done.

Different contraceptive methods had been discussed with the patient. As they had been using oral treatment for Crohn’s disease, they were not willing to have another pill to remember to take; they were also afraid of any gastrointestinal irritation. Long-acting reversible contraceptives and a vaginal ring had also been discussed, but the patient was afraid of anything being put into their body. The patient was keen to choose a method that would be easily planned as they had just started their university studies and their schedule was unpredictable and different every day. Therefore, they had decided to try a contraceptive patch. The patient had been precisely informed to place the first patch on the first day of their menstrual bleeding and to change it every 7 days. They had been asked to come for consultation after three cycles to assess the method’s tolerance.

During the patient’s second visit to the clinic, after about 2 months on transdermal contraception, they were generally satisfied with the method they had chosen. They stated that they had no difficulties in placing the patch and the adhesion was fine, even though they attended pool activities each week. The only side effect the patient reported was delicate breast discomfort; however, with noticeable decreasing tendency. They denied any gastrointestinal problems while using the patch.

CASE TWO

The next patient was a 27-year-old G2 para 2 White female, who sought contraceptive counselling. They had a history of hypothyroidism for a few years under endocrinologist care. Their BMI was 28 kg/m2. They had two vaginal births, 4 and 6 years ago. They were sexually active with their husband. The patient used oral pills but, due to their busy schedule, they sometimes forgot to take their daily dose. They had also tried to use a vaginal ring in the past but, due to recurrent vaginal infections and their husband’s discomfort during intercourse while the ring was inserted, they stopped using this method. These situations aggravated the patient’s mood, increased stress, and complicated sexual relations with their husband. Their notable medications included levothyroxine 75 mg once daily.

The patient’s gynaecological history includes menarche at 11 years and very painful and irregular menstrual cycles, occurring every few months; for this reason, they mainly used OC pills. The patient’s levels of thyrotropin, follicle-stimulating hormone, and prolactin were normal; findings on pelvic ultrasonography were also normal. Cytology testing was up-to-date, and negative for intraepithelial lesion or cancer. The patient’s physical exam was notable for acne and hirsutism, and their vitals were as follows: temperature: 36.9 °C; pulse: 76 beats per minute; respiratory rate: 20; and blood pressure: 118/75 mmHg.

The patient’s main goals for changing their hormone therapy continued to be to reduce pain during menstruation; meanwhile their goals for contraception were to reduce the stress of forgetting to take pills, to be highly effective in preventing pregnancy, long-lasting, and reversible.

After a long discussion with the patient, it was decided to use a transdermal contraceptive patch. Initially, it was recommended to use the patch for the first three cycles.

According to the product characteristics, it was ordered to be applied on Day 1 of withdrawal bleeding, the next patch on Day 8 of the cycle, and the last patch on Day 15 of the cycle. The patient was given detailed information on how to apply it. The patch may be placed on the skin of the upper arm, abdomen, or buttocks. The skin should be washed thoroughly; it must be clean, non-irritated, and hair-free. Manufacturers recommend that the patch is not applied to the breasts. There is a 1 week break in the fourth week, during which “withdrawal bleeding” should occur.9

After approximately 11 weeks, the patient returned to the office. Satisfied with the new contraceptive method, they reported only spotting during the first cycle with the second patch.

These complaints did not appear in the following cycles. The patient also did not notice any increase in body weight, which was noticeable while taking the contraceptive pill, and was associated with slight water retention. They did not report any skin problems or changes where the patch was applied.

CASE THREE

A 38-year-old female G4 para 3 presented at a routine postpartum appointment. They had their third caesarean section 6 weeks previously. The last caesarean has been complicated with urinary bladder lesion that had been sutured and a Foley catheter had been installed for 2 weeks post-operation. Breastfeeding was ineffective and the patient ceased lactation 10 days after delivery. Their gynaecologic anamnesis consists of polycystic ovary syndrome, with irregular menstrual bleedings prior to fertilisation. To get pregnant, they underwent mono-ovulation stimulation.

At the time of examination, the patient did not report any complaints. They were not bleeding or spotting, their blood pressure was normal, and BMI was 23 kg/m2. The uterus was well contracted, and their post-caesarean skin scar had healed normally. They denied any urinary problems.

The authors performed a transvaginal ultrasound, which revealed retroflexed uterus and a thin post-caesarean uterine scar measuring 1.5 mm and a noticeable niche underneath. The endometrium was thin and even, and ovarian echostructure was normal.

The patient asked for contraception. After having their third baby, they indicated a desire to avoid additional pregnancies. Moreover, they wanted to have menstrual bleedings regularly. They sought a method that would not be used daily as they were very occupied with their family.

Taking into consideration the ultrasound exam, the history of three caesarean sections, and retroflexed uterus, the authors did not consider an intrauterine system as the best option for this patient. Other options of long-acting contraception such as an implant or injection would not guarantee regular withdrawal bleedings. Therefore, after discussing all the pros and cons with the patient, a transdermal contraceptive patch was chosen. As they were not breastfeeding for more than 4 weeks, they were eligible for this method. The patient had been asked to apply the first patch as soon as they got their prescription, and to change it every 7 days.

Although the Evra patch can be proposed to almost any female who is eligible for hormonal contraception, there are some situations where this form of contraception would be specifically valuable. It does not require day-to-day remembering; is not, by any means, invasive; and is easy to control. This makes the method very appreciated by new contraception users, as well as patients who do not want or have contraindications for any oral and intravaginal or intrauterine hormonal devices.10

EVRA SAFETY PROFILE

The safety and tolerability of Evra have been analysed in a comparative study (812 patch, 605 OC) and pooled analysis (3,330 patch) for up to 13 treatment cycles.11

With the exception of application site reactions, dysmenorrhoea, upper respiratory tract infections, and breast symptoms, the incidence of adverse events with Evra is comparable to OCs:11

  • Expected with topical products, 94.5% of application site reactions were mild-to-moderate in severity with 2.6% of participants discontinuing for this reason11
  • Weight gain with Evra was minimal, with a mean increase of 0.3 kg from baseline to the end of treatment11
  • Breast symptoms include breast discomfort, engorgement and pain and were higher in cycles 1 and 2 only. Breast symptoms decrease to 0% during cycle 1311

Click here to view prescribing information.

UK-EVR-2200006 May 2022

References

1. Mansour D et al. Efficacy of contraceptive methods: a review of the literature. Eur J Contracept Reprod Health Care. 2010;15(1):4-16.

2. Wiegratz I, Thaler CJ. Hormonal contraception–what kind, when, and for whom? Dtsch Arztebl Int. 2011;108(28-29):495-505.

3. Blumenthal, PD, Edelman, A. Hormonal contraception. Obstet Gynecol. 2008;112(3):670-84.

4. Nall R. What to know about birth control nausea. 2019. Available at: https://www.medicalnewstoday.com/articles/326024. Last accessed: 1 February 2022.

5. United Nations Population Division (UNPD). Contraceptive use by method 2019: data booklet. 2019. Available at: https://digitallibrary.un.org/record/3849735?ln=en. Last accessed: 1 February 2022.

6. Henzl MR, Loomba PK. Transdermal delivery of sex steroids for hormone replacement therapy and contraception. A review of principles and practice. J Reprod Med. 2003;48(7):525-40.

7. Goa KL et al. Transdermal ethinylestradiol/norelgestromin: a review of its use in hormonal contraception. Treat Endocrinol. 2003;2(3):191-206.

8. Jick SS et al. (2010). Postmarketing study of ORTHO EVRA and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism. Contraception. 2020;81(1):16-21.

9. European Medicines Agency (EMA). Evra: summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/evra-epar-product-information_en.pdf. Last accessed: 1 February 2022.

10. Jakimiuk AJ et al. High levels of women’s satisfaction and compliance with transdermal contraception: results from a European multinational, 6-month study. Gynecol Endocrinol. 2011;27(10):849-56.

11. Sibai BM et al. A comparative and pool analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra). Fertil Steril. 2002;77(Suppl 2):S19-26.