Volume 6 - 1/2025, Short Review

Unmet needs of contraception in Italy and the role of transdermal contraception

Preview Pending Article

| Citation

Manuela Farris, Carlo Bastianelli

  • Manuela Farris Department of Maternal & Child Health, Gynecology and Urology, Sapienza, University of Rome, Rome, Italy
  • Carlo Bastianelli Faculty of Medicine and Dentistry, Sapienza, University of Rome, Rome, Italy

Abstract

Contraceptive usage remains prevalent in Europe, with the Italian population displaying a variety of contraceptive practices, including reliance on less effective methods and an unmet need for contraception. The Evra® transdermal contraceptive patch has been underutilized in recent years, despite its proven efficacy and convenience. This paper examines the contraceptive landscape in Italy, highlighting the need for improved counseling practices to address the unmet need for contraception. Additionally, it explores the role of the Evra® patch as a viable alternative, emphasizing its advantages and potential to meet the diverse contraceptive needs of Italian women, including postpartum women that do not breastfeed, users seeking to regulate bleeding patterns, as well as individuals that request convenient non-daily options. By addressing barriers such as misinformation, limited awareness, and provider biases, healthcare systems can better support women in selecting contraceptive methods that align with their preferences, lifestyles, and reproductive goals. The Evra® patch emerges as a promising option, offering high efficacy, convenience, and suitability for various user profiles. Integrating structured counseling practices and promoting non-daily contraceptive options like the Evra® patch can significantly contribute to reducing the unmet need for contraception and improving reproductive health outcomes in Italy.

Full article

Full Article

Introduction

Contraception is widely used across Europe, with 90% of women employing some form in 2015 [1]. A 2019 survey by the Italian National Statistics Institute (ISTAT) examined Italian women's contraceptive practices [2]. The male condom was the most common method used (35%), while oral contraception was adopted by about 20%, among the lowest rates in Europe. Additionally, 18% of Italian women relied on withdrawal, and 23% used no contraceptive method [2]. A study using a pregnancy risk model indicated that nearly a third of pregnancies in Italy are unintended due to inadequate contraception [3], highlighting a significant unmet need.

The Evra® transdermal contraceptive patch, available globally for two decades, offers high efficacy and improved compliance compared to oral contraception [4-7]. Despite new contraceptive methods, the patch has become underutilized [8]. Differences in counseling practices among healthcare providers contribute to the varying prescription rates [9-11]. Structured counseling plays a pivotal role in informing users about contraceptive options, associated risks, benefits, and promoting user autonomy, thereby reducing preferential prescribing. Multinational studies indicate that structured counseling increases the selection of non-daily, non-oral methods like the patch and vaginal ring, attributed to their convenience [12]. Furthermore, convenience and shared decision-making enhances correct and consistent use of the chosen contraceptive method [13,14]. In this article we will explore facets that lead to the unmet need in contraception within Italy, along with highlighting alternative methods like the Evra® patch that help address these unmet needs.

Access to contraception

Access to contraception is a fundamental human right, which aligns with Sustainable Development Goal 3.7, aiming for universal access to sexual and reproductive healthcare services [15]. Despite advancements in contraceptive use, a significant unmet need for contraception still remains, particularly in developing regions, due to various barriers such as geographical and financial constraints, health concerns, and lack of decision-making power [16]. Meeting this unmet need could prevent millions of unintended pregnancies, abortions, and maternal deaths annually [17].  Additionally, improving the quality of contraceptive counseling can enhance user satisfaction and method compliance and continuous use. While various frameworks exist that provide quality family planning services, there is no clear consensus on the best approach for delivering contraceptive counseling. In addition, limited guidance on counseling content and delivery mode, such as face-to-face versus digital support, still remains. Despite reviews examining counseling the impact of strategies on contraceptive behavior, there is mixed evidence, with a need for further research to comprehensively assess effectiveness and satisfaction outcomes.

Counselling variations

In Italy, gynecologists prescribe contraception, but women often rely on the internet or peers for information, with doctors being the last source. The CHOICE study (both US and EU) found that women are generally aware of only one or two contraceptive methods. In Italy, most doctors primarily discuss the pill, with 61% of pill users reporting it was recommended by their doctor [18]. Providing comprehensive information on all methods and making a joint decision is associated with higher satisfaction [19].  Effective contraceptive counseling in Italy needs improvement to ensure women are informed about all available methods. According to a questionnaire-based study, organized by the European Board and College of Obstetrics and Gynaecology and European Society of Contraception, relative to other European countries, Italy was rated as having a low quality of contraceptive counselling and care [20]. In Table 1, a comparative overview of contraceptive counselling and care in Italy relative to other European countries is presented based on the findings of Khattak et al. [20].

Aspect Italy Best-Performing    Countries Lowest-Performing    Countries
Access   to Contraceptive Services Basic to moderate access Netherlands,   UK, France (Easy/Very Easy) Romania,   Malta, Turkey (Difficult)
Quality   of Counselling Low to moderate Sweden,   France, UK (High/Very High) Malta,   Turkey, Romania (Low)
Professionals   involved Mainly   gynecologists UK,   Finland (multidisciplinary team) Belarus,   Malta (very limited variety)
Training   for physicians Available France,   UK, Finland (Structured programs) Greece, Malta,   Serbia (No training)
Training   for Nurses/Midwives Available Finland,   UK, France Austria, Portugal,   Serbia (No training)
Use   of Guidelines Relies   on international guidelines UK   (UKFSRH), Global (WHO) Some   countries report no guideline for   use
Emergency   Contraception (EC) Levonorgestrel   & Ulipristal available, partial OTC France,   Sweden (Full OTC access) Prescription-only   in several countries
Online   Counselling Services Available UK,   Denmark, Finland Not   available in 77% of countries
Table 1. Comparative overview of contraceptive counselling and care in Italy vs other European countries based on the findings of Khattak et al. [20].

Healthcare providers may underestimate the amount of information women want about contraception. The European Thinking About Needs in Contraception (TANCO) study revealed that while many women are satisfied with their current methods, they are interested in learning about all options [21]. Providers often underestimate this interest, especially in non-daily long-acting methods. Merki-Feld et al. [21] concluded that understanding women's needs and expectations could facilitate more informed choices and better discussions with healthcare providers, thus, enhancing the selection of appropriate methods [21]. These findings highlight the underestimated preference for convenient contraceptive methods.

Unmet needs in contraception

A recent study using a pregnancy risk model found that almost a third of pregnancies in Italy are unintended despite the prevalence of contraceptive methods used and available [3]. The Global Burden of Disease Study 2019 reported that users aged 15-19 years had the lowest demand satisfaction with modern contraceptive methods [16]. Policymakers should assess whether enhancing method variety or accessibility would better address the needs of groups with significant unmet needs [16].

Furthermore, many postpartum women have unmet family planning needs due to insufficient information and access to optimal contraceptive methods, highlighting the need for improved counseling services in maternity hospitals and family planning centers [22]. Despite discussions about future contraception, many postpartum women do not use highly effective methods, indicating an unmet need for contraceptive services [22].  Informing postpartum users about convenient non-daily methods, like transdermal contraception, can benefit postpartum women (when no longer breastfeeding) by helping them make informed choices suited to their lifestyle changes. Postpartum contraception is vital for adequate birth spacing, which is essential for maternal and infant health. A two-year birth interval could prevent numerous maternal deaths and reduce abortion rates globally [23,24]. However, many caregivers fail to capitalize on these opportunities during antenatal and postpartum visits, resulting in an unmet need for postpartum contraception in Italian women. For instance, a study with 436 postpartum participants found only 5.5% received information on contraceptive use [22].

An additional unmet need lies in the fact that combined hormonal contraception (CHC) can also allow women to regulate their menstrual bleeding, however many women are not aware of this. Although many women have negative feelings towards menstrual bleeding, many accept it as being necessary. A recent survey assessed Italian women's attitudes towards menstrual bleeding, their desire to reduce its frequency, and their knowledge of methods to achieve this [25]. An online survey, conducted on 1,072 women (18 to 40 years), found that while many viewed menstruations negatively, half were unaware of methods to suppress or reduce menstruation, and over half were reluctant to use contraceptive methods due to concerns about their 'unnaturalness'. This highlights a lack of knowledge about options to regulate menstrual cycles despite a desire for less frequent menstruation [25]. Healthcare providers should inform users about the option to regulate bleeding with CHCs, including Evra®. Counselling should extend beyond providing a prescription in order to include the health advantages of contraception and address concerns about bleeding patterns, including the option to schedule or avoid bleeding [26]. Integrating extended or continuous usage options into counseling sessions can help meet individual needs [27].

Transdermal contraception: Evra®

Evra® is a transdermal contraceptive patch, that was developed nearly two decades ago, designed to deliver both norelgestromin (NGMN) and ethinylestradiol (EE). This contraceptive method, administered via a 20 cm2 patch, offers 6 mg of NGMN and 600 μg of EE, releasing 203 μg of NGMN and 33.9 μg of EE per day onto the skin [4]. Its licensed regimen involves applying one patch weekly for three weeks, followed by a patch-free week [4].

Studies have shown the high contraceptive efficacy of Evra®, boasting an overall Pearl Index of 0.90 and a method failure Pearl Index of 0.72 [4]. The contraceptive efficacy and menstrual cycle control of the transdermal contraceptive patch was evaluated by pooling data from three pivotal, multicenter, open-label trials encompassing up to 13 treatment cycles per participant [28]. A total of 3,319 women were enrolled across 183 clinical centers. Participants used a regimen consisting of three consecutive 7-day patches followed by a 7-day patch-free interval per cycle [28]. The primary assessed outcomes were contraceptive efficacy and cycle control. The life-table estimates for overall and method-related contraceptive failure over 13 cycles were 0.8% (95% CI: 0.3%–1.3%) and 0.6% (95% CI: 0.2%–0.9%), respectively [28]. Notably, efficacy was consistent across age and racial subgroups [28]. Although contraceptive failure rates among women weighing <90 kg were low and evenly distributed across the weight spectrum [28]; contrarily, women with body weight ≥90 kg exhibited a potentially increased risk of contraceptive failure, indicating a possible weight-related reduction in efficacy. Breakthrough bleeding incidence was low and declined with continued use [28].

Notably, studies have shown that users prefer contraceptive methods that offer convenience and fit in their lifestyles [12]. This has also been highlighted in a Canadian study where 75% of participants favored the transdermal patch due to its ease of use [29]. Compared with other non-daily contraceptive methods, the patch is the only method that is applied outside of the body. As a result, users do not need to place the contraceptive method in their vagina or undergo a medical procedure, as required with the ring or long acting reversible contraceptives (LARCs). This allows users to have greater self-control of their contraceptive method. Moreover, Evra®'s formulation, particularly its progestin component, NGMN, combined with an estrogenic counterpart offers advantages for women with androgen excess disorders, given its minimal androgenic activity compared to other testosterone derivate progestins. Despite sharing common side effects with other CHCs, such as breast discomfort, Evra® is generally well-tolerated.

Various studies across different regions consistently report high satisfaction and compliance rates among Evra® users [30-32]. For instance, an open-label trial comparing Evra® with oral contraceptives (OCs) found higher compliance and treatment satisfaction with the patch due to its ease of use [33]. Similarly, studies conducted in Brazil and across eight European countries have shown a strong preference for Evra® over previous contraceptive methods, along with improvements in physical and emotional well-being and reduced premenstrual symptoms [29,30]. It is noteworthy that, unlike with OCs, satisfaction with the patch increases with age. This could be attributed to its convenient use, which becomes increasingly important as responsibilities accumulate with age, making Evra® potentially suitable for post-partum women who do not breastfeed. It is important to note that CHCs can impact lactation, including the quantity and composition of breastmilk. As a result, transdermal contraception is not recommended until post-partum women are no longer breastfeeding [4].

As with all CHCs, once contraindications have been ruled out, for users that are looking for a non-daily option, transdermal contraception should be considered as a viable option. The incidence of venous thromboembolism (VTE) associated with patch use is estimated to range from approximately 6 to 12 cases per 10,000 women per year [4]. In comparison, the incidence of VTE among users of combined oral contraceptives (COCs) containing levonorgestrel, norethisterone, or norgestimate is slightly lower, ranging from 5 to 7 cases per 10,000 women annually. However, it is important to note that the VTE risk associated with the contraceptive patch remains significantly lower than the risk observed during pregnancy or the postpartum period. In relation to perimenopausal women, transdermal contraception can also be a viable option to prevent pregnancy while also alleviating perimenopausal symptoms. It should be noted that contraceptive efficacy for CHCs, including transdermal contraception, may be reduced in women weighing 90 kg or greater [4].

Based on findings from the European CHOICE study, structured counseling has been shown to prompt a significant shift in contraceptive method preference among women, with 52% opting for a patch or ring over the pill [34]. This shift is often attributed to the perceived ease of use associated with monthly or weekly applications, compared to the daily regimen required by the pill. Many women find the convenience of less frequent application appealing.

In terms of information-seeking behavior, users commonly rely on the internet for contraceptive information and often arrive at the clinic with a predetermined decision. Young or first-time users may express concerns about the efficacy of the ring or patch compared to the pill, as well as a lack of peer experience with these methods.

Despite the potential benefits of non-daily options like the ring or patch, young users in Italy, who are typically less compliant, may still receive recommendations for the pill from healthcare providers. Media misinformation further complicates contraceptive counseling, necessitating the correction of prevalent myths before discussing contraceptive options.

Similar to other CHCs, the patch offers protection against ovarian cancer, a point that is often overlooked in counseling sessions. Additionally, individuals who engage in dieting or heavy alcohol consumption may find non-oral options like the patch advantageous, particularly in instances of vomiting from alcohol-induced bingeing, where the pill may not be suitable. Furthermore, studies have also reported that Evra® maintains adhesive reliability through 7 days of wear even under conditions of heat, humidity, and exercise [35].

Conclusions

In conclusion, the unmet contraceptive need in Italy arises from low usage of effective modern methods, reliance on less effective methods like withdrawal, and a high prevalence of unintended pregnancies despite contraceptive use. The underutilization of alternatives like the transdermal contraceptive patch contributes to this issue, partly due to varied counseling practices among healthcare providers. Addressing these needs requires increasing awareness about alternative options, providing structured counseling, and promoting more effective contraceptive methods to reduce unintended pregnancies.

Transdermal contraception is a well-established, effective option with high user satisfaction and compliance. Its convenient use and proven efficacy make it valuable for women seeking reliable contraception. Combating counseling heterogeneity and implementing structured counseling is vital, particularly in Italy where misinformation and limited awareness persist. By addressing these barriers and promoting informed decision-making, healthcare providers can better meet the contraceptive needs of Italian women. The Evra® patch is a promising option that is suitable for various user profiles. Including contraceptive counseling during pregnancy can help avoid unmet needs during postpartum period and inform users about options that meet their changing lifestyles. Promoting non-daily options like the Evra® patch can help regulate bleeding patterns, making Evra® a viable alternative to meet the diverse needs of Italian women.

References

  1. ESHRE Capri Workshop Group. Why after 50 years of effective contraception do we still have unintended pregnancy? A European perspective. Hum Reprod. 2018;33(5):777-783.
  2. Istituto Nazionale di Statistica (Istat). Health for All. June 2025. Available at: https://www.istat.it/it/archivio/14562
  3. Ciccarone A, Begovic I, Bruno GM, Russo A, Mirjalili N, Colombo GL. Il potenziale impatto della riclassificazione della pillola progestinica sulle gravidanze non pianificate in italia. Clinicoecon Outcomes Res. 2022;17:249–262.
  4. European Medicines Agency (EMA). EVRA Patch. Summary of Product Characteristics. 2012. Available at: https://www.ema.europa.eu/en/documents/product-information/evra-epar-product-information_en.pdf
  5. Galzote RM, Rafie S, Teal R, Mody S. Transdermal delivery of combined hormonal contraception: a review of the current literature. Int J Womens Health. 2017;9:315–321.
  6. Archer DF, Cullins V, Creasy GW, Fisher AC. The impact of improved compliance with a weekly contraceptive transdermal system (Ortho Evra®) on contraceptive efficacy. Contraception. 2004;69(3):189–195.
  7. Archer DF, Bigrigg A, Smallwood GH, Shangold GA, Creasy GW, Fisher AC. Assessment of compliance with a weekly contraceptive patch (Ortho EvraTM/EvraTM) among North American women. Fertil Steril. 2002;77(2 Suppl 2):S27-S31.
  8. Gemzell-Danielsson K, Farris M, Kopp-Kallner H, Lira J, Obiol M, Petta C. Statement on transdermal contraception as an underused option for unmet needs in contraception: the importance of structured counselling. Gynecol Reprod Endocrinol Metabol. 2023;4(2-3):48–54.
  9. Bitzer J, Cupanik V, Fait T, et al. Factors influencing women’s selection of combined hormonal contraceptive methods after counselling in 11 countries: Results from a subanalysis of the CHOICE study. Eur J Contracept Reprod Health Care. 2013;18(5):372-380.
  10. Reyes-Martí L, Rubio-Rico L, Ortega-Sanz L, et al. Contraceptive counselling experiences in Spain in the process of creating a web-based contraceptive decision support tool: a qualitative study. Reprod Health. 2021;18(1):237.
  11. Gambera A, Corda F, Papa R, et al. Observational, prospective, multicentre study to evaluate the effects of counselling on the choice of combined hormonal contraceptives in Italy—the ECOS (Educational COunselling effectS) study. BMC Womens Health. 2015;15:69.
  12. Relias Media. What do women want? The answer is simple: Convenient birth control. Contraceptive and technology update. February 1 2002. Available at: https://www.reliasmedia.com/articles/118524-what-do-women-want-the-answer-is-simple-convenient-birth-control
  13. DelBanco T, Daley J. Through the Patient’s Eyes: Strategies Toward More Successful Contraception. Obstet Gynecol. 1996;88(3 Suppl):41S-47S.
  14. Dehlendorf C, Levy K, Kelley A, Grumbach K, Steinauer J. Women’s preferences for contraceptive counseling and decision making. Contraception. 2013;88(2):250-256.
  15. United Nations. Sustainable Development Goals. Goal 3: Ensure healthy lives and promote well-being for all at all ages Available at: https://www.un.org/sustainabledevelopment/health/
  16. Haakenstad A, Angelino O, Irvine CMS, et al. Measuring contraceptive method mix, prevalence, and demand satisfied by age and marital status in 204 countries and territories, 1970–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2022;400 (10348):295-327.
  17. Guttmacher Institute. Adding it up: investing in contraception and maternal and newborn health. December, 2017. Available at: https://www.guttmacher.org/fact-sheet/adding-it-up-contraception-mnh-2017
  18. Johnson S, Pion C, Jennings V. Current methods and attitudes of women towards contraception in Europe and America. Reprod Health. 2013;10:7.
  19. Bitzer J, Oppelt PG, Deten A. Evaluation of a patient-centred, needs-based approach to support shared decision making in contraceptive counselling: the COCO study. Eur J Contracept Reprod Health Care. 2021;26(4):326-333.
  20. Khattak H, Tsiapakidou S, Mukhopadhyay S, et al. Variations in sexual and reproductive health services for the provision of comprehensive contraceptive and abortion services across Europe: A questionnaire-based study commissioned by the European Board and College of Obstetrics & Gynaecology (EBCOG) and European Society of Contraception (ESC). Eur J Obstet Gynecol Reprod Biol. 2024;299:350-358.
  21. Merki-Feld GS, Caetano C, Porz TC, Bitzer J. Are there unmet needs in contraceptive counselling and choice? Findings of the European TANCO Study. Eur J Contracept Reprod Health Care. 2018;23(3):183–193.
  22. Bastianelli C, Farris M, Benagiano G, D’Andrea G. Unmet needs and knowledge of postpartum contraception in Italian women. Clin Exp Obstet Gynecol. 2013;40(4):514-518.
  23. Campbell OM, Graham WJ; Lancet Maternal Survival Series steering group. Strategies for reducing maternal mortality: getting on with what works. Lancet. 2006;368(9543):1284-1299.
  24. Cleland J, Bernstein S, Ezeh A, Faundes A, Glasier A, Innis J. Family planning: the unfinished agenda. Lancet. 2006;368(9549):1810-1827.
  25. Bastianelli C, Grandi G, Farris M, et al. Attitudes towards menstruation: what women want? An Italian National Survey. Eur J Contracept Reprod Health Care. 2023;28(1):28-35.
  26. Schrager S, Larson M, Carlson J, Ledford K, Ehrenthal DB. Beyond Birth Control: Noncontraceptive Benefits of Hormonal Methods and Their Key Role in the General Medical Care of Women. J Womens Health (Larchmt). 2020;29(7):937-943.
  27. Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol. 2005;105(6):1389-1396.
  28. Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002;77(2 Suppl 2):S13-S8.
  29. Weisberg F, Bouchard C, Moreau M, et al.; NRGEEP-CON-401 Study Group. Preference for and satisfaction of Canadian women with the transdermal contraceptive patch versus previous contraceptive method: an open-label, multicentre study. J Obstet Gynaecol Can. 2005;27(4):350-359.
  30. Ferriani RA, Andrade RP, Neto LF, et al. Estudo multicêntrico Brasileiro – Adesivo contraceptivo transdérmico semanal: Preferência e satisfação das usuárias. Rev Bras Med. 2006;63(4):144–151.
  31. Jakimiuk AJ, Crosignani PG, Chernev T, 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):849-856.
  32. Urdl W, Apter D, Alperstein A, et al.; ORTHO EVRA/EVRA 003 Study Group. 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(2):202-210.
  33. Audet MC, Moreau M, Koltun WD, et al.; ORTHO EVRA/EVRA 004 Study Group. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA. 2001;285(18):2347-2354.
  34. Costa AR, Palma F, Sá JL, et al. Impact of a women’s counselling programme on combined hormonal contraception in Portugal–the IMAGINE Study. Eur J Contracept Reprod Health Care. 2011;16(6):409-417.
  35. Abrams LS, Skee DM, Natarajan J, et al. Pharmacokinetics of norelgestromin and ethinyl estradiol delivered by a contraceptive patch (Ortho Evra/Evra) under conditions of heat, humidity, and exercise. J Clin Pharmacol. 2001;41(12):1301-1309.

Conflict of interest Statement: Manuela Farris discloses speaker honoraria from Gedeon Richter. Carlo Bastianelli has no disclosures of interest.

Acknowledgement: Nazanin Hakimzadeh (Terminal 4 Communications, Hilversum, the Netherlands) provided Medical Writing support.

Funding: This work was funded by Gedeon Richter.

Publication Type: Review

Keywords: , , , ,

Citation: Farris M., Bastianelli C., Unmet needs of contraception in Italy and the role of transdermal contraception, GREM Gynecological and Reproductive Endocrinology & Metabolism (2025);

Published: October 10, 2025

ISSUE Volume 6 - 1/2025