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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 α -pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17 α -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% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing® is latex-free. 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.

In three large clinical trials of 13 cycles of NuvaRing® use, pregnancy rates were between one and two per 100 women-years of use. Table III lists the pregnancy rates for users of various contraceptive methods.

TABLE III: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR: UNITED STATES.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
Method Typical UseAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Perfect UseAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
  (1) (2) (3) (4)
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (one dose is two white pills), Alesse (one dose is five pink pills), Nordette or Levlen (one dose is four yellow pills).
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breast-feeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
Adapted from Hatcher et al., Contraceptive Technology, 17th Revised Edition. New York, NY: Irvington Publishers, 1998.
ChanceThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 85 85
SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film. 26 6 40
Periodic abstinence 25 63
  Calendar 9
  Ovulation Method 3
  Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2
  Post-Ovulation 1
Cap 1
  Parous Women 40 26 42
  Nulliparous Women 20 9 56
Sponge
  Parous Women 40 20 42
  Nulliparous Women 20 9 56
Diaphragm 20 6 56
Withdrawal 19 4
CondomWithout spermicides.
  Female (Reality) 21 5 56
  Male 14 3 61
Pill 5 71
  Progestin Only 0.5
  Combined 0.1
IUD
  Progesterone T 2.0 1.5 81
  Copper T 380A 0.8 0.6 78
  LNg 20 0.1 0.1 81
Depo-Provera 0.3 0.3 70
Norplant and Norplant-2 0.05 0.05 88
Female sterilization 0.5 0.5 100
Male sterilization 0.15 0.10 100

1 With spermicidal cream or jelly.


See all Nuvaring indications & dosage >>

NEWS HIGHLIGHTS

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

iMedicalApps: An App for Contraception Prescribing
Source: MedPage Today OB/Gyn [2017.05.18]
(MedPage Today) -- Lots of positives for new point-of-care app

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)

Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733) [Completed]
This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.

NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles [Terminated]
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.

Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing� [Completed]
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 focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was 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 recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included 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 translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.

NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment [Terminated]
The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.

A Study to Evaluate the Effectiveness of NuvaRing to Prevent Pregnancies in Chinese Women (P06450) [Completed]
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.

more trials >>

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

Based on a total of 27 ratings/reviews, Nuvaring has an overall score of 6.44. The effectiveness score is 9.41 and the side effect score is 6.81. 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 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.

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Page last updated: 2017-05-18

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