Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring) - Summary

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.

See all Nuvaring indications & dosage >>

NEWS HIGHLIGHTS

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

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

Plan B: Obama Administration to Drop Age Limits on OTC Sales
Source: MedPage Today OB/Gyn [2013.06.10]
WASHINGTON (MedPage Today) -- The Obama administration signaled its intent late Monday to stand down in the emergency contraception fray, announcing that it was dropping plans to appeal a Federal judge's decision to allow broad access to Plan B One-Step.

more news >>

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

A randomized controlled trial of NuvaRing versus combined oral contraceptive pills for pretreatment in in vitro fertilization cycles. [2011.09]
OBJECTIVE: To determine whether use of the NuvaRing (Merck) for pretreatment in IVF cycles would result in better cycle control and patient satisfaction versus a 30-mug oral contraceptive (OC) pill.

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...

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

Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers [Recruiting]
It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of inflammation.

Hypothesis:

The hypothesis is that NuvaRing® will alter inflammatory biomarkers of inflammation, such as vaginal defensin and cytokine levels, resulting in an overall anti-inflammatory milieu in the vagina.

Specific aims of this study are to:

1. Determine biomarkers of inflammation, including defensins and cytokines, concentrations

in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use

2. Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration before and after treatment with NuvaRing®

3. Monitor for changes in the Nugent score before and after NuvaRing® use

4. Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use

5. Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use

Methods This is a prospective, open-label, nonrandomized study. Participants will serve as their own controls. The Clinical Research Center of Eastern Virginia Medical School, Norfolk, Virginia, U. S.A. will be the only study site.

NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles [Recruiting]
Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in order to better control and also plan the onset of the ovary stimulation with gonadotropin.

Marvelon is taken daily as soon as menstruation starts for a period of 14 to 21 days. Ideally, it has to be taken at the same time everyday and not be forgotten. This may cause higher stress level for some users. Presently on the market, there is a ring-shaped contraceptive device inserted in the vagina at day 1 of the cycle called NuvaRing. The purpose of this device is similar to an oral contraceptive. However, the benefit of NuvaRing is that it can be left in place for a period of up to 35 days without any other manipulation and keep an adequate rate of hormone for contraception. Moreover, NuvaRing shows better hormone stability in the blood. Although the side effects and the benefits are comparable for the two treatments, some studies have shown that more patients would respect the treatment with NuvaRing and that the level of satisfaction would be higher in women using NuvaRing when contraception is needed.

The purpose of the study is to compare the rate of satisfaction as well as the level of stress in women using Marvelon daily or NuvaRing with single insertion in a long protocol. Moreover, this study allow us to verify if using NuvaRing, a vaginal contraceptive releasing constant daily doses for up to 35 days will allow us to facilitate the planning of In Vitro Fertilization cycles in long protocol.

A Study to Evaluate the Effectiveness of NuvaRing� to Prevent Pregnancies in Chinese Women (P06450 AM4) [Recruiting]
This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.

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.

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Reports of Suspected Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring) Side Effects

Pulmonary Embolism (880),  Deep Vein Thrombosis (553),  Headache (261),  Depression (245),  Anxiety (230),  Hypercoagulation (218),  Migraine (206),  Nausea (179),  Thrombosis (176),  Ovarian Cyst (158), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

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 22 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Acne and birth control
Dosage & duration:		one ring inserted monthly (dosage frequency: once a month) for the period of 4 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I switched from Diane 35, a birth control pills recommended specifically for acne and was very worried that the nuva ring would cause an acne flair up, as switching from Diane to Yasmine had. Fortunately my skin stayed just as clear and as a plus no more taking pills nightly
Side effects:		slight vaginal irritation at the end of a cycle, nothing even moderately serious though.
Comments:		Nuva Ring is a brand name birth control method which releases hormones through the vaginal walls. You insert a flexible plastic ring once a month for three weeks and it acts as birth control.

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.