IMPLANON SUMMARY
IMPLANON™ (etonogestrel implant) is an off-white, non-biodegradable, etonogestrel-containing single sterile rod implant for subdermal use. The implant is 4 cm in length with a diameter of 2 mm (see Figure 1). Each IMPLANON™ rod consists of an ethylene vinylacetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel (ENG), surrounded by an EVA copolymer skin. The release rate is 60-70 µg/day in week 5-6 and decreases to approximately 35-45 µg/day at the end of the first year, to approximately 30-40 µg/day at the end of the second year, and then to approximately 25-30 µg/day at the end of the third year. IMPLANON™ is a progestin-only contraceptive and does not contain estrogen. IMPLANON™ does not contain latex and is not radio-opaque.
IMPLANON™ (etonogestrel implant) is indicated for women for the prevention of pregnancy. IMPLANON™ is a long-acting (up to 3 years), reversible, contraceptive method. IMPLANON™ must be removed by the end of the third year and may be replaced by a new IMPLANON™ at the time of removal, if continued contraceptive protection is desired.
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NEWS HIGHLIGHTSMedia Articles Related to Implanon (Etonogestrel Subcutaneous)
US funding revamps African contraceptive drive (AFP)
Source: Y! Health News Search RSS Feed [2009.11.18]
AFP - A new 12 million dollar family planning drive launched here Wednesday highlights how Obama administration funding has revamped a contraception drive in Africa and developing states, UN officials said, noting a sharp turnaround from the Bush era.
Terrence Higgins Trust Welcomes Department Of Health Nursing Degree Announcement, UK
Source: HIV / AIDS News From Medical News Today [2009.11.15]
HIV and sexual health charity Terrence Higgins Trust has welcomed the announcement by the Department of Health that all new nurses will be educated to degree level from 2013. Terrence Higgins Trust (THT) currently employs nurses who work in Chlamydia screening programmes for young people, HIV testing clinics and clinics that offer contraception services and screening for sexually transmitted infections.
Published Studies Related to Implanon (Etonogestrel Subcutaneous)
The efficacy of Implanon for the treatment of chronic pelvic pain associated with pelvic congestion: 1-year randomized controlled pilot study. [2009.09]
OBJECTIVE: To evaluate the beneficial effects of Implanon on pelvic pain in women with pelvic congestion syndrome (PCS). The efficacy of pain control, amount and frequency of menstrual loss, degree of patient's satisfaction and objective pelvic venography scores were investigated... CONCLUSION: Implanon seems to be an effective hormonal alternative for long-term treatment of properly selected patients with pure PCS-related pelvic pain.
A randomized controlled trial of treatment options for troublesome uterine bleeding in Implanon users. [2009.08]
CONCLUSION: Mifepristone combined with either EE or doxycycline was significantly more effective than placebo in terminating an episode of bleeding in Implanon users. However there was no improvement in subsequent bleeding patterns. Trial registration number: ACTR # 012605000206628.
Implanon versus medroxyprogesterone acetate: effects on pain scores in patients with symptomatic endometriosis--a pilot study. [2009.01]
BACKGROUND: Implanon has been reported to be effective in the treatment of dysmenorrhea. We compared the therapeutic efficacies of depot medroxyprogesterone acetate (DMPA) and Implanon with regard to pain relief in women with endometriosis... CONCLUSION: Concerning pain relief, the therapeutic efficacy of the contraceptive implant Implanon is not inferior to that of DMPA in symptomatic endometriosis.
7alpha-methyl-19-nortestosterone (MENT) vs testosterone in combination with etonogestrel implants for spermatogenic suppression in healthy men. [2007.09]
Testosterone with a progestogen can suppress spermatogenesis for contraception... These data indicate the importance of the doses of progestogen and testosterone for optimum spermatogenic suppression while minimizing side effects.
Comparison of uterine concentrations of ethinyl estradiol and etonogestrel after use of a contraceptive vaginal ring and an oral contraceptive. [2006.01]
OBJECTIVE: To compare uterine tissue concentrations of ethinyl estradiol (EE) and etonogestrel (ENG) after one cycle of use of a contraceptive vaginal ring (NuvaRing; NV Organon, Oss, The Netherlands) or a combined oral contraceptive (COC)... CONCLUSION(S): Vaginal administration of hormones with NuvaRing did not produce elevated uterine concentrations of EE and ENG, compared with an oral contraceptive.
Clinical Trials Related to Implanon (Etonogestrel Subcutaneous)
Pharmacokinetics of Implanon in Obese Women [Recruiting]
Prior studies examining the pharmacokinetics, safety, and efficacy of the new
etonogestrel-containing single rod implantable contraceptive device, Implanon, did not
include women who exceeded 130% of ideal body weight. Yet, as these women comprise a
significant portion of the U. S. population, studies of Implanon in obese women are
essential. The proposed study represents an important first step in addressing the lack of
data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in
obese women during the first 6 months of use and to provide data on the acceptability, side
effect profile, and ease of insertion, palpation, and removal in these women. We also aim to
collect samples for future validation studies of the use of the blood spot (finger-stick
blood sample on filter paper) as a method of determining plasma etonogestrel.
A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate [Recruiting]
This trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on:
- the prostate volume and the urinary complaints;
- the urinary flow and the urinary volume in the bladder after voiding;
- the progression of the disease;
- the sexual function, well-being and urinary complaints-related Quality of Life. In
addition the safety and the way the drug is absorbed and excreted by the body will be
analyzed.
Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant [Recruiting]
A highly effective single rod contraceptive implant is now available for use in the US.
Delays in the insertion of the device until later in the postpartum period may negatively
impact initiation rates. The objective of this study is to compare outcomes of early
postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing
contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary
outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of
breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side
effects, time to resume sexual intercourse after delivery, and incidence of missed routine
postpartum follow-up. In addition, a subset of patients who randomize to early postpartum
insertion will have expressed breastmilk ascertained for nutrient composition.
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060) [Not yet recruiting]
This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind
trial of three different doses of etonogestrel releasing medicated intrauterine systems
(ENG-MIUS) in healthy parous women in need for contraception.
The primary trial objective is to explore safety and acceptability of three doses of an
ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
Acceptability of Long-term Progestin-only Contraception in Europe [Recruiting]
The study examines the use of Mirena or Implanon for long-term contraception in women. The
duration of therapy use is the key focus of the study. Also, any reasons for discontinuation
and the safety profile will be examined. In addition, patients are asked to fill out a short
questionnaire about their menstrual bleeding before and during therapy.
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