The transdermal patch and the vaginal ring: two novel methods of combined hormonal contraception

This article reviews two novel contraceptive methods that have become recently available in the United States: the transdermal patch and the vaginal ring. In general, newer methods of contraception are designed to make adherence easier for patients. The two contraceptive methods discussed in this article may help patients achieve this goal.     

Contraception during perimenopause

Perimenopause marks the transition from normal ovulation to anovulation and ultimately to permanent loss of ovarian function. Fecundity, the average monthly probability of conception, declines by half as early as the mid-forties, however women during the perimenopause still need effective contraception. Issues arising at this period such as menstrual cycle abnormalities, vasomotor instability, the need for osteoporosis and cardiovascular disease prevention, as well as the increased risk of gynecological cancer, should be taken into consideration before the initiation of a specific method of contraception. Various contraceptive options may be offered to perimenopausal women, including oral contraceptives, tubal ligation, intrauterine devices, barrier methods, hormonal injectables and implants. Recently, new methods of contraception have been introduced presenting high efficacy rates and minor side-effects, such as the monthly injectable system, the contraceptive vaginal ring and the transdermal contraceptive system. However, these new methods have to be further tested in perimenopausal women, and more definite data are required to confirm their advantages as effective contraceptive alternatives in this specific age group. The use of the various contraceptive methods during perimenopause holds special benefits and risks that should be carefully balanced, after a thorough consultation and according to each woman's contraceptive needs.     

Contraception during perimenopause.

Perimenopause marks the transition from normal ovulation to anovulation and ultimately to permanent loss of ovarian function. Fecundity, the average monthly probability of conception, declines by half as early as the mid-forties, however women during the perimenopause still need effective contraception. Issues arising at this period such as menstrual cycle abnormalities, vasomotor instability, the need for osteoporosis and cardiovascular disease prevention, as well as the increased risk of gynecological cancer, should be taken into consideration before the initiation of a specific method of contraception. Various contraceptive options may be offered to perimenopausal women, including oral contraceptives, tubal ligation, intrauterine devices, barrier methods, hormonal injectables and implants. Recently, new methods of contraception have been introduced presenting high efficacy rates and minor side-effects, such as the monthly injectable system, the contraceptive vaginal ring and the transdermal contraceptive system. However, these new methods have to be further tested in perimenopausal women, and more definite data are required to confirm their advantages as effective contraceptive alternatives in this specific age group. The use of the various contraceptive methods during perimenopause holds special benefits and risks that should be carefully balanced, after a thorough consultation and according to each woman's contraceptive needs.     

Nondaily contraceptive options user benefits, potential for high continuation, and counseling issues

Advances in contraception over the past decade have included an increasing number of methods that do not require daily or coital administration. Currently available reversible nondaily options include the transdermal patch, vaginal ring, contraceptive progestin injection, subdermal etonogestrel implant, levonorgestrel intrauterine system (LNG IUS), and copper intrauterine device (IUD). These methods have the attributes of convenience, high efficacy, ease of use, noncontraceptive benefits, and reversibility. Each method offers reliable contraception, with its own adverse effects and benefit-risk profile. Clinicians should be well-versed in the available reversible contraceptive methods to adequately counsel their patients. This is particularly pertinent when counseling women about female and male permanent sterilization (tubal ligation or vasectomy). Counseling before tubal ligation or vasectomy should include a review of the benefits of permanent sterilization and the risks unique to these procedures, such as the risks associated with minor surgery, anesthesia, or sedation. Counseling before permanent sterilization should also include the possible loss of noncontraceptive benefits related to hormonal contraception, the permanence of the procedure, risk of regret, and a review of all available contraceptive alternatives. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader should be able to summarize information about non-daily contraceptive options to allow patients to make well-informed decisions, distinguish differences between non-daily contraceptive choices to guide recommendations for care, and generate counseling plans and materials for contraceptive patients.     

New Developments in Vaginal Rings for Contraception

Over the last few decades, new contraceptives with lower concentrations of hormones administered through different routes have been developed. The vaginal contraceptive ring is a relatively new, effective, safe, self-administered hormonal contraceptive method that is increasingly being tested and used. Vaginal rings that release new progestins and estrogens are being developed to reduce side effects and risks, and offer new choices to users. Currently, there are only two commercially available contraceptive rings: a monthly ring containing etonogestrel and ethinylestradiol (NuvaRing®) and a progesterone-only ring for lactating women that can be used for three months (Progering®). To increase the use of this method, recent and ongoing studies are testing rings with progesterone receptor modulators, estradiol and antiretroviral drugs for their indications and safety.     

Recently approved and experimental methods of contraception

The U.S. Food and Drug Administration has recently approved two new contraceptive methods, and others are nearing approval. In addition, several innovative approaches to contraception are under investigation. This paper details the latest information on the following methods: Paragard Copper T 380A intrauterine device, cervical cap, NORPLANT, vaginal pouch, long-acting injectables, hormonal vaginal ring, transdermal patch, experimental male methods, inhibin, and contraceptive vaccines.     

Hormonale Kontrazeption in der Perimenopause

Perimenopause marks the transition from normal ovulation to anovulation. However, perimenopausal women may still be at risk for unintended pregnancy. Various contraceptive methods may be offered including oral contraceptives (OC), tubal ligation, intrauterine devices, barrier methods, hormonal injectables and implants. Furthermore, the contraceptive vaginal ring and the transdermal contraceptive system have been introduced recently. However, these new options have to be further investigated in perimenopausal women. Women should be informed that OC use until menopause or the mid-50s is both safe for healthy, non-smoking women and effective in easing perimenopausal symptoms. OC use during perimenopause can also help reduce risks of bone density loss, as well as endometrial, ovarian and colorectal cancer later in life.     

Contraceptive applications of estrogen

Estrogens are a primary component of several contraceptive methods: combined oral contraceptive pills, a combined injectable contraceptive, the combined contraceptive vaginal ring, the combination transdermal contraceptive patch, and combined emergency contraceptive pills. Contraceptive formulations that contain estrogen are referred to as combined contraceptives because they also contain some form of progestin. This article reviews the contraceptive methods containing estrogen, beginning with a discussion of combined oral contraceptive pills. Formulations and clinical management, mechanisms of action, noncontraceptive benefits of use, therapeutic uses in addition to contraception, side effects, contraindications to use, and drug-drug interactions are described. Information follows about the newer combined contraceptive products including the injection, vaginal ring, and patch. Finally, combined emergency contraceptive pills are reviewed. Thorough knowledge of the contraceptive methods containing estrogen enables clinicians to provide expert care for women using these products.     

Impact of standardized information provided by gynecologists on women’s choice of combined hormonal contraception

Abstract

This prospective interventional study was designed to determine the impact of providing standardized information on different methods of combined hormonal contraception on women’s selection of which method to use. A total of 952 Brazilian gynecologists were randomly selected. Each gynecologist recruited 15 consecutive patients for whom combined hormonal contraception was indicated. Each patient was asked which contraceptive method she would prefer (pill, patch, vaginal ring or injectable) before and after receiving a standardized explanation on each of these methods provided by her doctor. A total of 9507 women were included in the study. Prior to counseling, 66.5% of the women stated that they would prefer the pill, 17.9% the injectable, 8.9% the patch and 6.7% the vaginal ring. After counseling, 53.7% of the women stated that they would prefer the pill, 16.3% the injectable, 14% the patch and 16% the ring. In conclusion, the combined pill remains the most popular contraceptive method among Brazilian women; however, after receiving information on the various contraceptive methods available, the proportion of women choosing the vaginal ring or patch increased, while preference for the combined pill decreased.     

Does structured counselling influence combined hormonal contraceptive choice?

ABSTRACT

Objective To assess the effect of structured counselling on women's contraceptive decisions and to evaluate gynaecologists’ perceptions of comprehensive contraceptive counselling.

Methods Belgian women (18–40 years old) who were considering using a combined hormonal contraceptive (CHC) were counselled by their gynaecologists about available CHCs (combined oral contraceptive [COC], transdermal patch, vaginal ring), using a comprehensive leaflet. Patients and gynaecologists completed questionnaires that gathered information on the woman's pre- and post-counselling contraceptive choice, her perceptions, and the reasons behind her post-counselling decision.

Results The gynaecologists (N = 121) enrolled 1801 eligible women. Nearly all women (94%) were able to choose a method after counselling (53%, 5%, and 27% chose the COC, the patch, and the ring, respectively). Counselling made many women (39%) select a different method: patch use increased from 3% to 5% (p < 0.0001); ring use tripled (from 9% to 27%, p < 0.0001). Women who were undecided before counselling most often opted for the method their gynaecologist recommended, irrespective of counselling.

Conclusion Counselling allows most women to select a contraceptive method; a sizeable proportion of them decide on a method different from the one they initially had in mind. Gynaecologists’ preferences influenced the contraceptive choices of women who were initially undecided regarding the method to use.     

Impact of a women's counselling programme on combined hormonal contraception in Portugal – The IMAGINE Study

ABSTRACT

Background The aim of this health education project was to measure the impact of counselling about combined hormonal contraceptive (CHC) methods on the subsequent choice of method by Portuguese women.

Method This was a multi-centre study with a representative population, at the national and regional levels, of 2951 Portuguese women ≥ 16 years of age visiting the gynaecologist. Counselling on available CHC methods was provided using a single leaflet, and their CHC choice was assessed before and after counselling.

Results A combined oral contraceptive (COC) was the method preferred by the majority of the women prior to counselling. After counselling, 35% of women who initially had chosen the pill, switched to either the vaginal ring or the transdermal patch, and the difference was statistically significant. Ease of use was the major reason for choosing the COC, while a lower probability of omission was the reason for choosing the vaginal ring and the patch.

Conclusions The implementation of a counselling programme significantly affected contraceptive choices leading in a number of cases to the selection of alternatives better suited to women's lifestyle. Age and educational level are socio-demographic factors which play an important role.     

Hormonal contraceptive methodology: an historical review

The introduction of the first hormonal contraceptive was one of the most important events of the twentieth century for women. The availability of oral contraceptives (OCs) provided women with greater control over their reproductive lives. As OC usage steadily increased, so did concern over health risks associated with their use. Concluding that adverse events were dose-related, scientists sought to develop lower-dose formulations. In the four decades since the first OC, women seeking contraception have benefited from the development of non-oral hormonal delivery systems, including injectables, intrauterine devices, implants, a vaginal ring, and a contraceptive patch. It is hoped that this expanding menu of choices affords women opportunities to find methods better suited to their individual needs. Clinicians should continually evaluate their patients' hormonal contraceptive needs, and provide adequate counseling so that every woman is afforded the opportunity to achieve contraceptive success.     

New contraceptive methods

OBJECTIVE: To provide an update on the current trend toward increasing use of emergency postcoital contraception, continuous (or "extended-use") oral contraceptives (OCs) and longer-acting contraceptive delivery systems. DATA SOURCES: This review is based largely upon patient care-oriented clinical experience data, including some original work submitted to the U.S. Food and Drug Administration by the primary investigators of these novel methods, supplemented, when appropriate, with basic pharmacologic and pharmacokinetic information. METHODS OF STUDY SELECTION: This review is a distillation based on an exhaustive literature search of each of the following topics: emergency postcoital contraception, continuous (extended-use) oral contraception, the weekly patch, the monthly vaginal ring and the monthly injectable. The issue of OC formulations recently begun to be marketed in this country was excluded since they have been extensively reviewed elsewhere. RESULTS: Emergency postcoital contraception is highly effective, though not as effective as available proactive methods of hormonal contraception. Of the popular regimens available, all have similar efficacy; those without estrogen are associated with less nausea and vomiting. The prophylactic administration of an antiemetic 1 hour prior to the first contraceptive dose can mitigate this adverse side effect. Continuous (or "extended" use) of OCs has become increasingly popular. This can decrease or eliminate menstruation as well as several menstruation-related complaints (e.g., dysmenorrhea, menstrual migraines and premenstrual symptoms). Despite the fact that combination OC regimens offer highly reliable contraception as well as several noncontraceptive health benefits, they are limited by the issue of daily compliance. To address this limitation, several longer-acting delivery systems were recently developed. The weekly patch, monthly vaginal ring and monthly injectable have efficacy and side effect profiles similar to those of comparable OC formulations. They offer the advantages of longer action and lower and more steady steroid levels and are free of the challenges associated with daily compliance. CONCLUSION: We need to continue to develop new and highly effective means of contraception that offer women ease of use and minimal side effects, hence leading to successful and effective use.     

Long-acting hormonal contraception: assessing impact on bone density, weight, and mood.

The decline in unintended pregnancies and abortions in the United States has been attributed largely to increased use of two highly effective, hormonal contraceptive methods, depot medroxyprogesterone acetate injection (DMPA) and levonorgestrel implants (Norplant). Despite the efficacy and increasing acceptability of these long-term methods, some clinicians and women are reluctant to use them because of concerns regarding reduction in bone density with DMPA, and depressive symptoms and body weight issues with both injectables and implants. Recent multicenter experience showed no increase in depressive symptoms after 1 year's DMPA use and 2 years' Norplant use, even among users with the highest mean depressive symptom scores pre-therapy. Observational studies indicate that, as with other hormonal contraceptives and hormone replacement, DMPA does not cause significant weight gain, even during long-term use. Multicenter experience with the new soft-tubing Norplant product found an average annual pregnancy rate of <1% and a cumulative 5-year pregnancy rate of 4.2% in women weighing 70 kg or more--substantially lower than failure rates cited in the product labeling. Trends in bone density seen with DMPA appear similar to those during lactation. Subgroups of long-term DMPA users may experience a decrease in spinal bone density that appears to be reversible following discontinuation. A once-a-month injectable contraceptive combining 25 mg medroxyprogesterone acetate and 5 mg estradiol cypionate (Cyclo-Provera, Cyclofem or Lunelle), a 2-rod levonorgestrel system, and a single-rod 3-ketodesogestrel implant system may become available in the United States. Large-scale trials have established the safety, efficacy, and acceptability of Cyclo-Provera. In contrast to DMPA, users of Cyclo-Provera experience predictable, regular monthly bleeding, fewer discontinue due to bleeding-related problems. Fertility returns rapidly following discontinuation. A U.S. multicenter study is currently nearing completion.     

Innovations in contraception: a review

New forms of contraception have been developed to improve the safety and tolerability of contraceptive methods without compromising efficacy. The newest developments in contraception including low and ultra-low doses of estrogen, less-androgenic 19 nor-testosterone progestins, and the nonsteroidal progestin drospirenone, the Quick Start method to improve compliance of oral contraceptives, and the contraceptive transdermal patch, the vaginal estrogen-progestin ring, the levonorgestrel intrauterine system, and the hysteroscopic transcervical sterilization techniques are discussed.     

Whither methods for men? Emerging gender issues in contraception

Few would deny that the knowledge and use of the means to control fertility have contributed to women's empowerment. Yet in addition to being a right for women, contraception can also be a burden, and dissatisfaction with female-dependent methods is common. Men wanting to share responsibility for birth spacing have few reversible options at present but new reversible methods for men are under development. Acceptability was studied during a recent contraceptive trial of a prototype injectable hormonal method for men. Of the British men who participated in the trial and their women partners, many were dissatisfied with the pill and other female-dependent methods they had tried. This paper examines why the development of an effective, reversible, non-barrier contraceptive method for men is an important gender issue, and why prospects for its success could hinge on how it is perceived by women as well as by men.     

Counseling on vaginal delivery of contraceptive hormones: implications for women’s body knowledge and sexual health

Abstract

Background: Healthcare providers (HCPs) have an important role in helping women select the contraceptive method that best matches their needs and lifestyle. Recent surveys outline the need of women to be informed about all available choices, including the newest methods (particularly those not requiring daily administration), such as vaginal contraception.

Methods: The most relevant publications on combined contraceptive vaginal ring are revised in the context of counseling as an opportunity to empower women in term of vaginal health and sexual functioning.

Results: HCPs should explain the main characteristics of the combined contraceptive vaginal ring including the anatomical and physiological implications that make the vagina an ideal route of hormonal administration and the basic notions about functional modifications of the vagina during reproductive life. Clinical data on the vaginal ring should be summarized with regard to efficacy, tolerability, pharmacokinetics, cycle control and user acceptability, including recent findings on extra-contraceptive benefits (also compared to other hormonal contraceptives) on the vaginal flora and on sexual function.

Conclusion: Vaginal contraception offers various benefits and should always be discussed during contraceptive counseling. An open dialogue about vaginal contraception will also help enhance body knowledge and sexual health.     

The combined contraceptive vaginal device (NuvaRing): a comprehensive review.

OBJECTIVES: The aim of this study is to review the development of NuvaRing over the past decade to illustrate its use-effectiveness and acceptance as an alternative contraceptive option for women. METHODS: The data were extracted from the literature using computerised MEDLINE system. NuvaRing is a new combined hormonal contraceptive vaginal ring made of ethylene-vinyl-acetate copolymer, releasing 120 microg etonorgestrel and 15 microg ethinyloestradiol per day. This ring is inserted on any day from day 1 to day 5 of a menstrual cycle for 21 days, thereafter removed for 7 days ring-free period and discarded. RESULTS: Complete inhibition of ovulation is observed during treatment with this device. Clinical exposure to NuvaRing for 1786 women-years has resulted in 21 pregnancies, giving a Pearl Index of 1.18. Withdrawal bleeding (4.7-5.3 days) is regular (97-99% of cycles) with rare incidence of irregular bleeding (2.6-6.4%). The cycle control is good with the use of this combined contraceptive vaginal ring. NuvaRing is well tolerated and accepted by women as compared to oral pill. CONCLUSIONS: NuvaRing is an effective vaginal contraceptive option for women. However, further study is needed for monitoring its long-term effectiveness and impact on patient's quality of life since the NuvaRing is marketed in many countries.     

Transdermal hormonal contraception: benefits and risks

Transdermal drug delivery systems have been available in the United States for >20 years. Since the introduction of the first transdermal patch (scopolamine) for the treatment of motion sickness, >35 transdermal patch products have been approved by the US Food and Drug Administration for a variety of indications that include hormone replacement therapy, nicotine replacement therapy, chronic pain (fentanyl), angina (nitroglycerin), hypertension (clonidine), and more recently, overactive bladder (oxybutynin), and contraception (ethinyl estradiol/norelgestromin). Clinical data demonstrated the efficacy and safety of the contraceptive patch; however, concerns regarding estrogen levels and reports of venous thromboembolism led to the development of 2 epidemiologic studies and, subsequently, revised product labeling. Despite this, the contraceptive patch may be an appropriate option for some patients.     

Update on contraception

Since the introduction of hormonal contraceptives in the 1960s, great advances have been achieved in contraception. Biological effects of sexual steroids as well as risks and benefits of oral contraception are better estimated. After the development of a new hormone-containing intra-uterine system, new hormone delivery systems offer women safe and effective contraceptive options. These new options that combine high efficacy and ease of use should allow better acceptance and compliance than daily pill ingestion and should then reduce the high rate of unintended pregnancies terminated by elective abortion. Transdermal contraceptive system and vaginal ring offer a promising innovative approach in pregnancy prevention. Subdermal implants give women the choice of a highly effective contraceptive system in spite of significant side effects. New hormonal delivery systems such as injectables are under development. Hysteroscopic tubal sterilization is now also available and is a very effective procedure. This wide variety of new contraceptive methods offers a marked improvement from previous medications for users by providing better efficacy and tolerability.