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)
Millions Still Lack Access to Modern Contraception, Study Says
Source: MedicineNet Birth Control Specialty [2013.03.12]
Title: Millions Still Lack Access to Modern Contraception, Study Says
Category: Health News
Created: 3/11/2013 8:36:00 PM
Last Editorial Review: 3/12/2013 12:00:00 AM
Give Teens Access to Emergency Contraception, Pediatricians Say
Source: MedicineNet Miscarriage Specialty [2012.11.26]
Title: Give Teens Access to Emergency Contraception, Pediatricians Say
Category: Health News
Created: 11/26/2012 10:35:00 AM
Last Editorial Review: 11/26/2012 12:00:00 AM
Copper IUD Does Not Increase Period Pain
Source: Sexual Health / STDs News From Medical News Today [2013.05.10]
Previous scientific studies have suggested that women who use a copper IUD for contraception suffer from worse period pain, but a study at the Sahlgrenska Academy, University of Gothenburg, that followed 2,100 women over a 30-year period shows that this is not the case...
Published Studies Related to Implanon (Etonogestrel Subcutaneous)
Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. [2009.12]
BACKGROUND: The effects of etonogestrel (ETG)-releasing contraceptive implant during the immediate postpartum period on maternal safety are unknown... CONCLUSION: The insertion of ETG-releasing contraceptive implant during the immediate postpartum period was not associated with deleterious maternal clinical effects or with significant maternal metabolic alterations or decreased infant weight gain.
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.
Clinical Trials Related to Implanon (Etonogestrel Subcutaneous)
Immediate vs. Delayed Postpartum Implanon [Not yet recruiting]
The investigators are examining if there is a difference in continuation rates of the
etonogestrel contraceptive implant between women who have the device placed immediately
after delivery, before leaving the hospital, and women who have the device placed at the
routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1: 1 ratio,
for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks
after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to
complete a brief survey. The investigators hypothesize that continuation rates of Implanon
will be higher in the immediate postpartum placement arm than in the delayed placement arm.
Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern? [Not yet recruiting]
The purpose of the study is to examine how well three months preceding use of Cerazette
progestin only pill predicts the bleeding pattern during following Nexplanon implant use.
Same-day Long-acting Reversible Contraception for Medication Abortion [Recruiting]
Contraception after abortion is an important public health issue, as women who have an
abortion are at high risk for additional unintended pregnancy. In the context of first
trimester medical abortion, the standard of care is to administer long-acting reversible
contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone
acetate (DMPA), at a follow-up appointment after the abortion.
The investigators plan to conduct a prospective pilot study to evaluate the satisfaction of
subjects who have either the contraceptive implant or DMPA given on the first day of medical
abortion, as opposed to at a follow-up appointment. The investigators will also assess the
continuation of DMPA and Implanon at 3, 6, 9, and 12 months after the initial date of
administration. In addition, the investigators will assess the total days of bleeding after
the abortion, follow-up rate for evaluation of completion of medical abortion, and efficacy
of medical abortion.
A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA.
They will be asked to fill out questionnaires during the course of the study, and will be
followed for one year. The study duration including data analysis will be two years.
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.
New Treatments for Troublesome Bleeding in Implanon Users [Not yet recruiting]
Most Implanon users experience a reduction in the frequency and volume of menstrual
bleeding, but a substantial minority experience unpredictable and frequent and/or prolonged
episodes of bleeding. This is a double blind, placebo controlled, randomised study with an
additional randomised non-blinded arm. Two hundred women between the ages of 18-45 years,
who are Implanon users with prolonged or frequent breakthrough bleeding (WHO definition)
will be recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to
Marvelon 7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a
daily menstrual diary chart for a minimum of 90 days prior to randomisation, and will be
enrolled into the treatment phase provided that they have met one of the World Health
Organization criteria for prolonged or frequent bleeding Following the initial 90 day
record, eligible women will begin designated treatment on day 1 of the next episode of
bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of
that bleeding/spotting episode and will continue through 90 days.
Reports of Suspected Implanon (Etonogestrel Subcutaneous) Side Effects
Pregnancy With Implant Contraceptive (98),
Medical Device Complication (91),
Abortion Spontaneous (56),
Maternal Exposure During Pregnancy (56),
NO Adverse Event (55),
Device Breakage (41),
Metrorrhagia (40),
Menorrhagia (37),
Weight Increased (36),
Device Dislocation (35), more >>
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Page last updated: 2013-05-10
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