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Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring) - Summary

 



BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use combination hormonal contraceptives, including NuvaRing®, should be strongly advised not to smoke.

 

NUVARING SUMMARY

NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17(alpha)-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17(alpha)-pregna-1,3,5(10)-trien-20-yne-3, 17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing® is made of ethylene vinylacetate copolymers (28% and 9% vinyl acetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing® has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.

NuvaRing® is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NuvaRing® is highly effective if used as recommended in this label.
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NEWS HIGHLIGHTS

Media Articles Related to Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring)

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.

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Published Studies Related to Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring)

Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. [2005.03]
This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 microg of ethinylestradiol (EE) and 120 microg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 microg of levonorgestrel (LNG) and 30 microg of EE...

Absence of pharmacokinetic interactions of the combined contraceptive vaginal ring NuvaRing with oral amoxicillin or doxycycline in two randomised trials. [2005]
BACKGROUND: Two pharmacokinetic studies were performed to investigate whether there is any interaction between etonogestrel or ethinylestradiol released from the combined contraceptive vaginal ring NuvaRing and concomitant treatment with orally administered amoxicillin or doxycycline... CONCLUSION: The results from these studies demonstrate the absence of pharmacokinetic interactions between etonogestrel and ethinylestradiol released from NuvaRing and the oral antibiotics amoxicillin and doxycycline, suggesting that contraceptive efficacy would also be unaffected.

A comparative study on the effects of a contraceptive vaginal ring NuvaRing and an oral contraceptive on carbohydrate metabolism and adrenal and thyroid function. [2004.09]
OBJECTIVES: To compare carbohydrate metabolism, adrenal and thyroid function during use of a combined contraceptive vaginal ring (NuvaRing, NV Organon, Oss, The Netherlands) with those of a combined oral contraceptive... CONCLUSIONS: Both the vaginal ring and the oral contraceptive have no clinically relevant effects on carbohydrate metabolism, adrenal or thyroid function.

The combined contraceptive vaginal ring, NuvaRing, and tampon co-usage. [2004.03]
We investigated the effect of tampon co-usage on systemic exposure to etonogestrel (ENG) and ethinylestradiol (EE) from the combined contraceptive vaginal ring, NuvaRing. One cycle of ring use consists of 3 weeks of ring use followed by a 1-week ring-free period...

The contraceptive vaginal ring, NuvaRing, and antimycotic co-medication. [2004.02]
We investigated the effect of antimycotic co-medication on the systemic exposure to etonogestrel (ENG) and ethinylestradiol (EE) released from the contraceptive vaginal ring, NuvaRing. Different formulations of miconazole nitrate and single as well as multiple dosing were investigated during two separate randomized, open-label, crossover studies...

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Clinical Trials Related to Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring)

Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing® [Completed]
The purpose of this research study is to evaluate the best way to manage breakthrough spotting and bleeding during an extended use regimen of NuvaRing®. Ease of use and acceptability of a flexible regimen of NuvaRing® will also be evaluated. A comparison of cyclic mood symptoms, pelvic pain, and headaches will be made between a standard 21/7 regimen and an extended regimen.

Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing® [Recruiting]
There are over 60 million women of reproductive age in the U. S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women.

Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women.

This investigation will focus on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study is a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24. 9 and obese women are those with a BMI 30-39. 9. We will recruit forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of 34 subjects (17 normal weight, 17 obese). We will compare mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers include sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translate to understanding contraceptive-mediated suppression of ovarian function in these two groups. We will also have subjects log patterns of ring use and bleeding patterns during the study period.

Acceptability of NuvaRing to College Women [Recruiting]
The purpose of this study is to compare the use and attitudes of the vaginal contraceptive ring NuvaRing® to the oral contraceptive pill Ortho Tri-Cyclen® Lo among college women. Both NuvaRing® and OrthoTricyclen® Lo are approved for use by the Food and Drug Administration (FDA). The information gathered from this study may help improve contraceptive use among college women.

PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra [Completed]
This is an open-label prospective, multicenter, randomized trial to compare continuation rates into the fourth cycle of women using either the NuvaRing or OrthoEvra. Five hundred women will be recruited at 9 centers nationwide to be randomly assigned to use either the NuvaRing or OrthoEvra for four months. Women must either be on the pill or have recently stopped the pill and be relatively satisfied with oral contraceptive use to qualify for enrollment. Two visits and two phone calls will be required.

Acceptablity of the NuvaRing Among Students [Recruiting]
The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 18 ratings/reviews, Nuvaring has an overall score of 7. The effectiveness score is 9.22 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Nuvaring review by 23 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Contraceptive
Dosage & duration:   1 Ring (dosage frequency: once a month) for the period of For about 2 years
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Treatment benefits were pregnancy prevention and regulation of menstrual cycle.
Side effects:   There were no know side effects caused by the treatment. I was very happy with the absence of side effects and the overall simplicity of the drug.
Comments:   The NuvaRing was inserted once a month and kept in place for three weeks. After the third week, the ring was removed so that a menstrual cycle could ensue. After 7 day, a new ring was inserted. There was no pain associated with the insertion or removal of the ring, nor was there any discomfort during sexual intercourse. Overall I am very pleased with the NuvaRing and will continue to use it until I decide to become pregnant.

 

Nuvaring review by 29 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Contraception
Dosage & duration:   Single (dosage frequency: once a month) for the period of six months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Required only one application per month, rather than having to take a pill everyday. Was also a lower dosage than the pill, which seems better. Because it is not ingested there was no nausea.
Side effects:   Lower doses can lead to a slight increase in PMS symptoms such as cramping, but these can be combated with mild pain relievers. Sometimes can be felt during intercourse.
Comments:   A plastic ring which releases hormones over a period of three weeks to provide contraceptive benefits. It is inserted into the vagina after your period, left for three weeks and then removed to allow for the next period.

 

Nuvaring review by 46 year old male patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Birth Control
Dosage & duration:   Standard NuvaRing Insert (dosage frequency: inserted once each month) for the period of 2 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   None
Side effects:   Within 2 months, I developed deep vein thrombosis in my left leg and pulmonary emboli in my lungs. Multiple blood clots in my lungs almost killed me. I was lucky to live because the clot lodged in parts of my lungs that were not fatal.
Comments:   Doctor inserted the NuvaRing during the office visit. No literature was provided so was not given the easy opportunity to read about side effects. There was no discussion with the doctor about side effects.

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Page last updated: 2009-11-18

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