Pharmacokinetics of etonogestrel released from the contraceptive implant Implanon®

Wenzl, René; Beek, Agaath van; Schnabel, Peter; Huber, Johannes

doi:10.1016/s0010-7824(98)00110-3

Cited by 73 publications

(41 citation statements)

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“…The ethylene vinyl acetate copolymer of Implanon allows controlled release of hormone over 3 years of use. 17 Each implant is provided in a disposable sterile inserter for subdermal application (Fig. 2).…”

Section: Description and Pharmacologymentioning

confidence: 99%

“…18 Potential explanations include differences in the release mechanism or that ENG is chiefly bound to albumin which is not affected by varying physiologic endogenous estradiol concentration, whereas LNG is mainly bound to sex hormone binding globulin. 17 Estradiol (E2) levels initially decrease to early follicular-phase range after insertion of the ENG implant. 21 This initial decrease is followed by a gradual rise in E2 levels.…”

Section: Description and Pharmacologymentioning

confidence: 99%

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The Contraceptive Implant

Hohmann

Creinin²

2007

Clinical Obstetrics &Amp; Gynecology

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Contraceptive implants provide long-acting, highly effective reversible contraception. Currently, the only subdermal implant available to women in the United States is the single rod etonogestrel implant, Implanon (N.V. Organon, Oss, the Netherlands) approved by the Food and Drug Administration in July 2006. Implanon is currently approved for 3 years of use, provides excellent efficacy throughout its use, and is easy to insert and remove. Similar to other progestin-only contraceptives, Implanon can cause irregular vaginal bleeding. Implanon has been shown to be safe to use during lactation, may improve dysmenorrhea, and does not significantly affect bone mineral density, lipid profile, or liver enzymes.

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Section: Description and Pharmacologymentioning

confidence: 99%

Section: Description and Pharmacologymentioning

confidence: 99%

The Contraceptive Implant

Hohmann

Creinin²

2007

Clinical Obstetrics &Amp; Gynecology

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“…If these methods failed to locate the implant, the Sponsor recommended serum etonogestrel level measurement to confirm presence or absence of the implant. A central Sponsor laboratory performed serum etonogestrel level quantification by radioimmunoassay with a lowest detectable level of 30 pg/mL [6,7].…”

Section: Methodsmentioning

confidence: 99%

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience

et al. 2017

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Objective: The objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP). Study design: US health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localizationor removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA. Results: Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization-or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal. Conclusion: Events related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant. Implications: This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide.

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“…Implanon ® subdermalni implant (etonogestrel 68 mg) (Organon, Holandija) sastoji se od jednog cilindričnog implanta (4 cm x 2 mm) gde membrana od EVA kopolimera bez aktivne supstance okružuje jezgro sa hormonom suspendovanim u EVA kopolimeru. Period kontraceptivne zaštite iznosi 3 godine i oslobađa se prosečno 30-40 mcg/24 h etonogestrela (najpre tokom prvog meseca 60-70 mcg/24 h, a pri kraju treće godine 25-30 mcg/24 h) [66,67]. U Evropi je u upotrebi od 1998.…”

Section: Subdermalni (Supkutani) Progestinski Implantiunclassified

Pharmaceutical-technological aspects of therapeutic systems for hormonal contraception

Djekić¹,

Primorac²

2016

Arh farmaciju

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Univerzitet u Beogradu -Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Vojvode Stepe 450, 11221 Beograd, Srbija Kratak sadržajUpotreba terapijskih sistema za hormonsku kontracepciju (TSHK) predstavlja značajan alternativni vid sprečavanja neplanirane trudnoće u odnosu na primenu hormonskih kontraceptiva per os, pri čemu se otklanja rizik od gastrointestinalnih neželjenih reakcija, omogućava smanjenje terapijske doze, učestalosti primene i sistemskih neželjenih dejstava i povećava nivo adherence. Do sada su razvijeni terapijski sistemi tipa transdermalnih flastera, subdermalnih (supkutanih) implanata, vaginalnih prstenova i intrauternih terapijskih (dostavnih) sistema (IUS) za hormonsku kontracepciju progestinima (progesteron, levonorgestrel, etonogestrel, nestoron) ili kombinacijama progestina i estrogena (norelgestormin + etinilestradiol, gestoden + etinilestradiol, etonogestrel + etinilestradiol, levonorgestrel + etinilestradiol, nestoron + etinilestradiol, nestoron + estradiol). U radu su prikazane glavne karakteristike navedenih tipova TSHK, kao i specifičnosti farmaceutskih proizvoda ove vrste u pogledu sastava i primene. Opisani su glavni mehanizmi za postizanje kontrolisanog produženog oslobađanja hormona i efikasnost za isporuku aktivnih supstanci kod različitih TSHK. Predstavljeni su najznačajniji savremeni pristupi u dizajnu terapijskih sistema ove vrste sa ciljem da se pojednostavi njihova primena, poboljša podnošljivost, prihvatljivost i terapijska efikasnost, a ukazano je i na mogućnost korišćenja novih tehnologija u razvoju terapijskih sistema za višenamensku prevenciju začeća i infekcije virusom humane imunodeficijencije (human immunodeficiency virus, HIV).Ključne reči: terapijski sistemi za hormonsku kontracepciju; transdermalni flaster; subdermalni (supkutani) implant; vaginalni prsten; intrauterini terapijski (dostavni) sistem; progestini; estrogeni; kontrolisano/produženo oslobađanje; tehnologije za višenamensku prevenciju.

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Pharmacokinetics of etonogestrel released from the contraceptive implant Implanon®

Cited by 73 publications

References 4 publications

The Contraceptive Implant

The Contraceptive Implant

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience

Pharmaceutical-technological aspects of therapeutic systems for hormonal contraception

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