Transdermal contraception methods: today’s patches and new options on the horizon

Nelson, Anita L.

doi:10.1517/14656566.2015.1022531

Cited by 8 publications

(8 citation statements)

References 63 publications

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“…The SECURE trial results led to the FDA approval of TWIRLA R in February 2020 as a contraceptive method for women with BMI < 30 kg/m 2 . TDS addresses a gap in the contraceptive landscape by offering nonobese women a nondaily transdermal contraceptive option that reduces estrogen exposure with favorable efficacy, safety, and tolerability [1,15] .…”

Section: Discussionmentioning

confidence: 99%

Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

Nelson¹,

Kaunitz

Kroll

et al. 2021

Contraception

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Objective: To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLA R) containing levonorgestrel (LNG) and ethinyl estradiol (EE). Study design: This single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days offtreatment/patch-free week). We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used. ✩ Clinical trial registration: This clinical trial was registered at www.ClinicalTrials. gov as: NCT02158572; Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System. The URL can be found at: https:// clinicaltrials.gov/ct2/show/NCT02158572. ✩✩ Funding: This study was funded by Agile Therapeutics, Inc., Princeton, NJ. Medical writing was provided by PharmaWrite, LLC, and was funded by Agile Therapeutics, Inc. Agile Therapeutics, Inc. provided a full review of the article and had a role in the design, execution, data collection and analysis, reporting, and funding of the study. ★ Implications: TDS (120 μg/day levonorgestrel and 30 μg/day ethinyl estradiol) is an effective, low-dose transdermal contraceptive patch with favorable tolerability profile approved for prevention of pregnancy in women with BMI < 30 kg/m 2. TDS has reduced effectiveness in women with BMI ≥30 kg/m 2 .

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Section: Discussionmentioning

confidence: 99%

Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

Nelson¹,

Kaunitz

Kroll

et al. 2021

Contraception

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“…TDES tenders sustaining administration of drug through the skin, which maintains stable plasma drug concentrations and avoids peaks and troughs 18. Reductions in bioavailability because of first-pass hepatic metabolism and enzymatic degradation in the gastrointestinal tract, which are seen with oral drug administration, are avoided 19.…”

Section: Discussionmentioning

confidence: 99%

An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch

Zhang¹,

Li²,

Xiong³

et al. 2017

DDDT

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We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE)/gestodene (GSD) transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet®) were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS) assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration (Cmax), extended time to reach the Cmax and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration–time curve (AUCs) of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations.

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“…Transdermal delivery of hormones helps address poor adherence and fl uctuation of hormones due to pharmacokinetic variations of serum hormonal levels associated with COCs. [33][34][35][36] Similar to a bandage, a small adhesive patch is placed on the lower abdomen, buttocks, upper arm, or upper torso (excluding the breast), worn continuously for 1 week, and is removed and replaced immediately by a new patch weekly for 3 weeks, followed by a patch-free week when the menstruation occurs. Alternatively, a new patch can be placed weekly without any breaks for continuous use.…”

Section: A 23-year-old Needs Birth Control That Will Provide Predicta...mentioning

confidence: 99%

Update on current contraceptive options: A case-based discussion of efficacy, eligibility, and use

Fiffick

Iyer

Cochran³

et al. 2023

CCJM

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With high rates of unintended pregnancy in the United States, it is crucial for clinicians to be well-informed about the full spectrum of contraceptive options to improve reproductive autonomy. We review new contraceptive options including a nonhormonal intravaginal gel, hormonal contraceptives in the form of new pills, patches, and vaginal rings, and combined hormonal contraceptives that contain new estrogens as alternatives to ethinyl estradiol. We review updated prescribing methods for several established hormonal contraceptives such as depot medroxyprogesterone acetate, which is now available for subcutaneous self-injection. Additional choices of available contraceptive methods have important clinical implications that may remove unnecessary barriers to contraceptive use. KEY POINTSCertain long-acting reversible contraceptive methods can prevent pregnancy beyond the approved duration of use. However, this does not allow for extending the duration of use for lowest-dose progestin intrauterine devices.Intravaginal contraceptive gel offers a nonhormonal contraceptive alternative.Contraceptives with longer approved durations of use or that do not require frequent access to healthcare professionals can improve adherence and outcomes. ■ NONHORMONAL CONTRACEPTIVE INTRAVAGINAL GELA 47-year-old with latex allergy presents to the offi ce. She is interested in contraception, but does not want anything that contains hormones.

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Transdermal contraception methods: today’s patches and new options on the horizon

Abstract: Given the recent increased use of first tier contraceptive methods (Intrauterine devices and implants), there may be interest in new patches. Price will influence their popularity. However, a new nondaily delivery system with lower estrogen levels will provide an important option to women.

Cited by 8 publications

References 63 publications

Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch

Update on current contraceptive options: A case-based discussion of efficacy, eligibility, and use

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