Transdermal Contraceptives Research Articles

Pharmacist Provision of Hormonal Contraception in the Oregon Medicaid Population.

To describe early utilization of pharmacist prescription of contraception in Oregon's Medicaid program. Using Oregon Medicaid claims data, we conducted a retrospective analysis and quantified overall and monthly trends in pharmacist-prescribed contraceptives from January 1, 2016, to December 31, 2017. Our population was restricted to patients obtaining a new prescription for oral and transdermal methods and who had continuous Medicaid coverage during the study period. We summarized demographic and utilization characteristics, including whether patients were continuing or switching methods or initiating contraception. New prescriptions were those written to patients who did not have one for hormonal contraception in the prior 30 days. To assess program safety, we examined rates of prescriptions to patients with medical contraindications to contraceptive use. Among the 3,614 patients receiving a new prescription for oral or transdermal contraceptives in the Oregon Medicaid program from all health care providers, 367 (10%) received their prescription from a pharmacist. Five months after implementation, pharmacists filled an average of 61 prescriptions per month as the prescriber. Most claims originated from retail chain pharmacies (94%) in urban locations (71%). The majority of patients who were prescribed contraception by pharmacists (73.8%) had no history of contraceptive prescriptions in the preceding 30 days (n=252). Ages ranged from 13 to 49 years, fewer patients lived in a rural location (35.7%), most received a combined hormonal pill (90.5%), and the average day's supply dispensed was 65 (range of 21-364 days). Fewer than 5% (12) of patients had a diagnostic code indicating a possible contraindicating comorbidity. Among Medicaid enrollees, we found that 10% of all new oral and transdermal contraceptive prescriptions were written by pharmacists.

Stagnant contraceptive sales after the Zika epidemic in Brazil

Objectives: Our aim was to assess national hormonal and non-hormonal contraceptive sales in Brazil after the Zika virus outbreak. Methods: Pharmaceutical companies based in Brazil provided data on monthly sales from September 2016 to June 2017. Data from both the public and private sectors were obtained about sales of registered, available modern contraceptive methods: combined oral contraceptive pill; progestin-only pill; vaginal and transdermal contraceptives; injectable contraceptives; long-acting reversible contraceptive (LARC) methods, including the copper-releasing intrauterine device, the levonorgestrel-releasing intrauterine system and the etonogestrel-releasing subdermal implant; and emergency contraceptive pills. Results: Seventy-eight percent of sales comprised pills, patches and vaginal rings (11.1–13.8 million cycles/units per month), followed by emergency contraceptive pills (1.8–2.6 million pills), injectables (1.2–1.4 million ampoules) and LARC methods (6500–17,000 devices). Conclusions: The data showed much higher sales of short-acting methods compared with more effective LARC methods. The public sector needs to strengthen its focus on ensuring better access to LARC methods through a systematic approach ensuring regular supply, improved professional skills and better demand generation to couples wishing to avoid or delay pregnancy. In Zika virus-affected areas, many women of reproductive age may want to delay or postpone pregnancy by using an effective LARC method. The public sector should review its policies on LARC, as the need for these methods especially in Zika virus endemic areas may increase. A clear emphasis on quality in services, access and use is warranted.

Contraceptive sales in the setting of the Zika virus epidemic.

STUDY QUESTIONHas there been any influence of the Zika virus (ZIKV) outbreak on the sales of contraceptive methods in Brazil?SUMMARY ANSWERContraceptive sales in the 24 months of evaluation showed little variation and no significant change has been observed since the ZIKV outbreak.WHAT IS KNOWN ALREADYTransmission of ZIKV is primarily by Aedes aegypti mosquitoes; however, sexual transmission has also been described. The association of several birth defects and the ZIKV infection during pregnancy has been established, and it was estimated in Bahia, Brazil that the infection rate could range from 10% to 80%. The World Health Organisation (WHO) declared the cluster of microcephaly cases and other neurological disorders a health emergency on 1 February 2016. The Brazilian government also made recommendations for women who were planning to become pregnant and who reside in ZIKV-affected areas to reconsider or postpone pregnancy.STUDY DESIGN, SIZE, DURATIONThe objective of this study was to assess the sales of contraceptive methods in Brazil, tracking it from before and through the ZIKV outbreak. We obtained information from all pharmaceutical companies based in Brazil and from the manufacturers of long-acting reversible contraceptives (LARCs), including the copper-intrauterine device (IUD), the levonorgestrel-releasing intrauterine system (LNG-IUS) and implants, about contraceptives sales in the public and private sectors between September 2014 and August 2016.PARTICIPANTS/MATERIALS, SETTING, METHODSWe analyzed the data for: (i) oral contraceptives, i.e. combined oral contraceptives (COC) and progestin-only pills (POP), and vaginal and transdermal contraceptives, (ii) injectable contraceptives, i.e. once-a-month and depot-medroxyprogesterone acetate, (iii) LARCs and (iv) emergency contraceptive (EC) pills.MAIN RESULTS AND THE ROLE OF CHANCEMonthly sales of COC, POP, patches and vaginal rings represent the major sales segment of the market, i.e. 12.7–13.8 million cycles/units per month (90%). The second largest group of sales was injectables, representing 0.8–1.5 million ampoules per month (9.5%). Following this, are LARC methods with sales of 37 000–41 000 devices per month (0.5%). It is important to note that although the peak months of sales were different for each group of contraceptives, there were no significant differences overall between the months of observation. The EC pill sales were between 1.0 million and 1.3 million of pills per month.LIMITATIONS, REASONS FOR CAUTIONAlthough the use of contraceptive methods was already high and no change was noted, the ZIKV outbreak may have changed the pregnancy intentions of Brazilian women. Consequently, the number of women planning pregnancy may be lower than that recorded. The contraceptive sales figures did not include condoms. Since condoms might not only prevent pregnancies, but also sexual transmission of ZIKV, this lack of information is a limitation.WIDER IMPLICATIONS OF THE FINDINGSThe results from this assessment showed that the sales of contraceptives presented little variation during the ZIKV outbreak in Brazil. Furthermore, it is possible that access to LARC methods was limited. Although we did not investigate the reason for low LARC uptake, we suspect that it is due to lack of availability of LARC in the public sector, the high cost of the methods and the incomplete insurance coverage on contraception for women. Projections estimate millions of additional cases of ZIKV transmission. Thus, a coordinated response is needed to ensure access to a wide range of contraceptive methods for women during the ZIKV outbreak. In conclusion, this assessment of contraceptive sales in Brazil identifies challenges in contraceptive access, especially for LARC methods, and represents an alternative source of data to help us understand the trends in demand for contraception in ZIKV-affected areas.STUDY FUNDING/COMPETING INTEREST(S)This study received partial financial support from Fundação de Apoio à Pesquisa do Estado de São Paulo (FAPESP) award # 2015/20504-9 and from an anonymous donor. The funding sources did not play a role in the study design, in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the article for publication. The authors declare no conflict of interest associated with this study.TRIAL REGISTRATION NUMBERN/A

New and emerging contraceptive options: a focus on transdermal contraception

New and emerging contraceptive options: a focus on transdermal contraception Bettina Böttcher, Ludwig WildtDepartment of Gynecologic Endocrinology and Reproductive Medicine, Innsbruck Medical University, Innsbruck, AustriaAbstract: Transdermal contraception is a convenient way of hormonal contraception that allows weekly application of a patch for 3 consecutive weeks followed by a patch-free week. Efficacy, side effects, advantages, and disadvantages as well as patient satisfaction with this formulation are discussed in this short review. The first patch, introduced in 2002, contained ethinylestradiol and norelgestromin. Recently, a new patch containing gestodene as the gestagen component has been developed. Early data for this formulation are presented.Keywords: transdermal contraception, skin patch

Contracepção em mulheres com condições clínicas especiais. Critérios médicos e elegibilidade

Pregnancy planning is important for the physical, mental, and social health of women and families. For women with underlying medical disorders, pregnancy planning assumes even greater importance, because ensuring a healthy woman and healthy child becomes more challenging. Unfortunately, some medical conditions also complicate the ability to use reliable contraception safely. Although numerous studies have addressed the safety and effectiveness of hormonal contraceptive use in healthy women, data are far less complete for women with underlying medical problems or other special circumstances. Using the best available scientific evidence and based on the American College of Obstetrics and Gynecology Practice Bulletin, this review provides information to help clinicians and women with coexisting medical conditions to make decisions regarding the selection and appropriateness of various hormonal contraceptives. The review includes recent advances in the development of oral contraception, emergency contraception, injectable contraception, vaginal rings, subdermal implants, transdermal contraception and intrauterine devices.

Formulation and optimization of desogestrel transdermal contraceptive patch using crystallization studies

Levonorgestrel (LNG) is the most commonly used progestin in contraception. In this study, we report the use of an alternative progestin, desogestrel, for transdermal contraception. The drug was found to be significantly more permeable as compared to LNG (p<0.05). Crystallization studies were used to select the best adhesive among acrylate (Duro-Tak 87-4098 and Duro-Tak 87-202A) and polyisobutylene (PIB, Duro-Tak 87-608A) pressure sensitive adhesives by determining the drug's saturation solubility in them. The use of copovidone and mineral oil as formulation excipients was investigated to increase drug loading in the PIB adhesive. Physical characterization of the patches was performed using in vitro drug release, content analysis, patch weight and thickness variations and rolling ball tack and peel adhesion studies. Optimized patches were evaluated for in vitro transdermal delivery across hairless rat skin. The saturation solubility of desogestrel was found to be approximately 49.3% (w/w) and 55.6% (w/w) in Duro-Tak 87-4098 and Duro-Tak 87-202A acrylate adhesives, respectively. The saturation solubility of desogestrel was significantly lower (3-4%, w/w) in the PIB adhesive. Mineral oil (10%, w/w) and copovidone (30%, w/w) were found to be optimum for increasing drug loading and patch cosmetics. Results from the physical characterization studies suggest that a uniform and reproducible 7 day drug-in-adhesive patch could be developed.

O448 OVULATION INHIBITION OF A NEW TRANSDERMAL (TD) CONTRACEPTIVE PATCH (ETHINYLESTRADIOL [EE] 0.55 MG/GESTODENE [GSD] 2.1 MG) IN WOMEN STRATIFIED BY BODY MASS INDEX (BMI)

International Journal of Gynecology & ObstetricsVolume 119, Issue S3 p. S420-S420 Free communication (oral) presentations O448 OVULATION INHIBITION OF A NEW TRANSDERMAL (TD) CONTRACEPTIVE PATCH (ETHINYLESTRADIOL [EE] 0.55 MG/GESTODENE [GSD] 2.1 MG) IN WOMEN STRATIFIED BY BODY MASS INDEX (BMI) M. Merz, M. MerzSearch for more papers by this authorC. Zurth, C. ZurthSearch for more papers by this authorK. Bangerter, K. BangerterSearch for more papers by this author M. Merz, M. MerzSearch for more papers by this authorC. Zurth, C. ZurthSearch for more papers by this authorK. Bangerter, K. BangerterSearch for more papers by this author First published: 22 October 2012 https://doi.org/10.1016/S0020-7292(12)60878-9AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume119, IssueS3Abstracts of XX FIGO World Congress of Gynecology and ObstetricsOctober 2012Pages S420-S420 RelatedInformation

Transdermal Contraception as a Model for Adolescent Use of New Methods

To examine the factors related to adolescents' decisions to use the transdermal contraceptive patch (patch) so as to develop a model for understanding how adolescents decide to use new contraceptive methods. We conducted in-depth semi-structured interviews with 18 young women aged 15-21 years who had experience using the patch. Data were analyzed using a two-stage method informed by grounded theory. We constructed a two-level model, encompassing individual, social, and environmental factors, to explain adolescents' decisions to use a new method of hormonal contraception. Social and environmental influences on the decision-making process included media, social network experiences and opinions, healthcare providers, and partner relationships. These in turn affected the following individual factors in the decision to use the patch: individual characteristics, method knowledge and beliefs, method support, and past contraceptive experience. The newness of the patch permeated all levels of the decision-making process. This model provides a framework for understanding the use of new contraceptive methods and can inform clinical strategies for contraceptive counseling with adolescents.

High levels of women's satisfaction and compliance with transdermal contraception: results from a European multinational, 6-month study

Objective. To investigate compliance, satisfaction, and preference in women using a transdermal contraceptive patch.Methods. Women (18–46 years) from eight European countries used contraceptive patches (norelgestromin 6 mg, ethinylestradiol 600 μg) for six, 4-week treatment cycles. Compliance, satisfaction, and preference were assessed after 3 and 6 cycles and study completion using self-report methods.Results. Of the 778 participants, 36.8% (n = 287) used no contraception at baseline. The most common methods were oral contraceptives (67.9%, n = 334) and barrier methods (21.5%, n = 106). Of oral contraception users, 63.5% (n = 212) were satisfied or very satisfied with their previous method, but compliance was poor with 77.8% (n = 260) reporting missed doses. After 3 and 6 cycles, >80% of all included women were satisfied or very satisfied with the patch. At study completion, most participants (73.7%) reported a preference for the patch compared to their previous method. Of 4107 cycles, 3718 (90.5%) were completed with perfect compliance. Two pregnancies occurred during this study, representing a Pearl Index of 0.63. No new safety issues were identified and the patch was well tolerated.Conclusion. Women were highly satisfied with transdermal contraception and preferred this form of family planning over their previous method. Transdermal contraception represents a valuable addition to contraceptive options with potential to offer high compliance and efficacy.

Systemic photosensitivity due to a contraceptive patch

Hormonal contraceptives are a known but rarely reported cause of photosensitivity. A 35-year-old female developed several episodes of a prurigionous papulovesicular eruption located on sun-exposed areas that resolved without scarring in days. She had been using a transdermal contraceptive (EVRA: norelgestromin and ethinyloestradiol) for 3 years, and once it was stopped, the patient became asymptomatic. She had another episode after the use of oral contraceptives (YAZ: ethinyloestradiol and drospirenone). The biopsy of the lesions showed a spongiotic dermatitis. Minimal erythema dose was diminished when the patient was using EVRA and YAZ and became normal when they were withdrawn. Phototesting with UVA, photopatch testing and blood porphyrins were normal. Antinuclear antibodies were 1/80 initially and were 1/320 6 months later. Anti-deoxyribonucleic acid antibodies, extractable nuclear antigens, anti Ro and Anti La were negative and no systemic symptoms had developed. When all hormonal contraceptives were stopped, the patient became asymptomatic. We report a case of systemic photosensitivity induced by the contraceptive patch. To the best of our knowledge, no other cases induced by transdermal contraceptives have been reported previously.

Two-fold higher risk of VTE with transdermal contraceptives

Two-fold higher risk of VTE with transdermal contraceptives

Hipertensión arterial y anovulatorios transdérmicos

Cardiovascular complications are one of the risks of hormonal contraception use (a two-fold risk of stroke and ischemic infarct and a four-fold risk of thromboembolic complications). Although the development of hypertension is infrequent, cases of accelerated hypertension accompanied by renal failure have been described. This adverse effect has been reported in relation to oral contraceptives but there are no references in the literature to the use of transdermal contraceptives, despite differences in the pharmacodynamics between the two routes of administration. We report the case of a 22-year-old woman who developed malignant hypertension with renal failure after replacing oral contraceptives for the transdermal patch. The hypertension resolved after discontinuing transdermal contraceptive use. Further studies are required to clarify this possible association but this isolated case highlights the importance of blood pressure measurement in the monitoring of hormonal contraception users.

Eligibility Criteria in Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users

Dore, David D. PharmD, PhD; Norman, Heather MS; Seeger, John D. PharmD, DrPH Author Information

New technologies in contraception

New technologies in both reversible contraception and sterilisation are described. The review includes recent advances in the development of oral contraception, emergency contraception, injectable contraception, vaginal rings, subdermal implants, transdermal contraception, intrauterine devices, spermicides and barrier methods. It also covers methods of transcervical female sterilisation and more easily reversible male sterilisation. The emphasis is on the technology and its safety and effectiveness. Hormonal delivery systems are described in some detail. Mention is also made of research into vaccines and male hormonal methods, where progress has been disappointing.

Trends in prescribing patterns of hormonal contraceptives for adolescents

Background Little is known regarding how prescribing patterns of hormonal contraceptives to adolescents in the United States have changed over time as new formulations become available and knowledge of thrombosis risk increases. Desogestrel and high-dose estrogen-containing formulations have been associated with a higher risk of thrombosis than other methods. Study design We used the National Ambulatory Medical Care/National Hospital Ambulatory Medical Care surveys to describe trends in contraception prescriptions for 11- to 21-year-old females between 1993 and 2004. Results The majority of prescriptions arose from obstetrics/gynecology clinics. The proportion of desogestrel-containing prescriptions was ∼10% throughout the study period. Ortho Evra (transdermal norelgestromin, ethinyl estradiol) and Yasmin (oral drospirenone, ethinyl estradiol) accounted for a steadily increasing proportion of prescriptions. Conclusion With regard to contraception and thrombosis risk, a significant minority of adolescents are prescribed desogestrel-containing contraceptives, and a greater number are exposed to higher levels of estrogen from transdermal contraception. Future studies are needed to evaluate the absolute risk of thrombosis in adolescents using these formulations so clinicians have accurate safety information when prescribing to this unique population.

Effects of Oral and Transdermal Hormonal Contraception on Vascular Risk Markers

To compare the effects of oral and transdermal contraceptives containing similar hormone formulations on vascular risk markers. We conducted a randomized, investigator-blinded, crossover, clinical trial with 24 healthy women, aged 18-35 years, who received 2 months of transdermal or oral contraceptive, 2 months washout, then 2 months of the alternative medication. The transdermal contraceptive contained 0.75 mg ethinyl estradiol and 6 mg norelgestromin. The oral contraceptive contained 35 mcg ethinyl estradiol and 250 mcg norgestimate. Blood samples taken before and after each treatment were analyzed in batch for D-dimer, von Willebrand factor, factor VIII, total and free protein S, antithrombin, fibrinogen, C-reactive protein, and normalized activated protein C sensitivity ratio (nAPCsr) determined with two thrombin generation-based assays, the alpha2macroglobulin-thrombin end point method (alpha2M-IIa) and calibrated automated thrombinography. Repeated measures analysis of variance was used for analysis. For both contraceptives (transdermal, oral) there were significant declines in free (19%, 11%) and total protein S (19%, 13%) and antithrombin (13%, 10%); increases in fibrinogen (8%, 10%), C-reactive protein (220%, 292%), nAPCsr alpha2M-IIa (81%, 61%), and nAPCsr calibrated automated thrombinography (102%, 68%), all P<.05. Transdermal contraceptives had a greater effect than oral contraceptives on free protein S (P=.07), nAPCsr alpha2M-IIa (P=.06), and nAPCsr calibrated automated thrombinography (P=.03). Oral and transdermal contraception with similar hormones had similar adverse effects on vascular risk markers. This suggests that this transdermal contraceptive has at least a similar thrombosis risk as its oral counterpart. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00554632 I.

There is a similar risk of nonfatal venous thromboembolism (VTE) between transdermal and oral contraceptives

There is a similar risk of nonfatal venous thromboembolism (VTE) between transdermal and oral contraceptives

There is a similar risk of nonfatal venous thromboembolism (VTE) between transdermal and oral contraceptives

There is a similar risk of nonfatal venous thromboembolism (VTE) between transdermal and oral contraceptives

Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users

To estimate the incidence of venous thromboembolism, acute myocardial infarction, and ischemic stroke among transdermal contraceptive system users compared with users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol. We began with insurance claims data from UnitedHealthcare. We identified women exposed to the transdermal contraceptive system or norgestimate-containing oral contraceptives from April 2002 through December 2004. Outcomes were confirmed from medical records. We calculated incidence rates and age-adjusted incidence rate ratios. In a nested case-control analysis, we investigated and controlled for confounding. There were 49,048 woman-years of transdermal contraceptive system exposure and 202,344 woman-years of norgestimate-containing oral contraceptives exposure. There was a more than two-fold increase in the venous thromboembolism rate (incidence rate ratio 2.2, 95% confidence interval [CI] 1.3-3.8) among transdermal contraceptive system users (20 cases, 40.8 per 100,000 woman-years) compared with norgestimate-containing oral contraceptives users (37 cases, 18.3 per 100,000 woman-years). Acute myocardial infarction occurred in three transdermal contraceptive system users compared with seven among norgestimate-containing oral contraceptives users (incidence rate ratio 1.8, 95% CI 0.5-6.8). No strokes occurred among transdermal contraceptive system users, whereas 10 occurred among norgestimate-containing oral contraceptives users. In the nested case-control analysis, after exclusions for high-risk factors, the odds ratio for venous thromboembolism was 2.4 (95% CI 1.1-5.5). There was a more than two-fold increase in the risk of venous thromboembolism associated with use of the transdermal contraceptive system. Acute myocardial infarction and stroke occurred too rarely to ascertain precise risk estimates. II.

High estrogenic impact on the liver by transdermal contraceptive patch

Evaluation of: White T, Ozel B, Jain JK, Stanczyk FZ. Effects of transdermal and oral contraceptives on estrogen-sensitive hepatic proteins. Contraception 74, 293–296 (2006).In a randomized trial, the effects on sex hormone-binding globulin (SHBG), corticosteroid-binding globulin (CBG), thyroxin-binding globulin (TBG) and C-reactive protein (CRP) of three cycles of treatment with a contraceptive patch containing ethinylestradiol (EE) and norelgestromin versus treatment with an oral contraceptive (OC) containing EE and norgestimate were compared. There was a significantly higher increase in the levels of SHBG and TBG during treatment with the patch than with the OC, whereas the estrogen-induced rise in CBG and CRP was similar. The results suggest a higher impact on estrogen-sensitive hepatic proteins of the contraceptive patch than of an OC due to the higher exposure of the women to EE. It has been reported that the relative risk of venous thromboembolism increases during treatment with the transdermal con...