NuvaRing

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NuvaRing
NuvaRing is a flexible plastic ring.
Background
B.C. type Hormonal
First use 2001
Failure rates (first year)
Perfect use 1%
Typical use 1-2%
Usage
Duration effect 4 weeks
Reversibility 0-4 weeks
User reminders Inserted for 3 weeks and then removed for a gap week
Clinic review Annual
Advantages and Disadvantages
STD protection No
Weight No proven effect
Periods Periods do not begin while ring is inserted.
Benefits Easy insertion and removal, only requires action every 1-3 weeks.

NuvaRing is the trade name for a combined hormonal contraceptive vaginal ring manufactured by Organon that is available by prescription. It is a flexible plastic (ethylene-vinyl acetate copolymer) ring that releases a low dose of a progestin and an estrogen over 3 weeks.

NuvaRing was first approved in The Netherlands on February 14, 2001, then by all 14 other countries then in the European Union on June 12, 2001, and in the United States by the FDA on October 3, 2001.[1] NuvaRing was first marketed in the United States in July 2002, followed by several other European countries in late 2002.[2] In March 2007, Organon announced the market launch of NuvaRing in Australia, bringing the total number of countries where NuvaRing is available to 32. NuvaRing is currently used by approximately 1.5 million women worldwide.[3]

Contents

[edit] Use

The currently approved NuvaRing regimen specifies insertion of the ring into the vagina for a three-week period, then removal of the ring for one week, during which the user will experience a menstrual period. The break week with NuvaRing is comparable to the placebo week for combined oral contraceptive pills ("the Pill"), and the contraceptive effect is maintained during this period. Extended use regimens (7-week, quarterly, or annual) involving back-to-back use of (2, 4, or 17) rings have been studied in clinical trials, but are not currently approved.[4][5][6]

Insertion of the ring is comparable to insertion of other vaginal rings. The muscles of the vagina keep NuvaRing securely in place, even during exercise or sex. Women can check the contraceptive ring periodically with their finger. In rare instances, NuvaRing may fall out during sexual intercourse, while straining during a bowel movement, or while removing a tampon.[7][8]

Contraceptive efficacy is not reduced if the ring is removed or accidentally expelled and is left outside of the vagina for less than three hours. If the ring has been out of the vagina for more than three continuous hours, contraceptive efficacy may be reduced and a backup method of contraception must be used until the ring has been used continuously for a subsequent seven days.[7][8]

[edit] Benefits

The benefits of the ring include:

[edit] Side effects

The NuvaRing, shown with a U.S. quarter for scale
The NuvaRing, shown with a U.S. quarter for scale

In two large studies, over a one year period, 15.1% of users discontinued NuvaRing because of adverse events. Device-related adverse events (foreign body sensation, coital problem, or expulsion) were the most frequently reported adverse events that resulted in discontinuation (by 2.5% of users). Device-related adverse events were reported at least once during the one year study period by 4.4% of NuvaRing users.[10]

The most common adverse events reported by 5 to 14% of the 2501 women who used NuvaRing in five clinical trials were: vaginitis (14.1%), headache (9.8%), upper respiratory tract infection (8.0%), leukorrhea (5.8%), sinusitis (5.7%), nausea (5.2%), and weight gain (4.9%).[8][15][16] NuvaRing is weight neutral.[17][18] Additional side effect information is provided in the NuvaRing full prescribing information.[8][16]

Etonogestrel, the specific progestin used in NuvaRing, is the active metabolite of the inactive prodrug desogestrel, one of two third-generation progestins found in some epidemiological studies of combined oral contraceptive pills to be associated with a higher risk of venous thrombosis than combined oral contraceptive pills containing certain second-generation progestins. Because hormones are released continuously from NuvaRing, peak and total estrogen and progestin doses are significantly lower than with combined oral contraceptives, although it is not known whether this lowers the risk of blood clots.[8]

Side effects not observed in the clinical trial but widely reported in online boards are vaginal dryness, pain during sex, depression, feelings of anxiety, mood swings and loss of sexual drive.

[edit] Lawsuit

In March 2008, a lawsuit was filed against the manufacturers, distributors, and marketers of NuvaRing. The plaintiff alleges that these companies concealed the health risks associated with using the device, which is claimed to have cause the death of the plaintiff's wife.[19]

[edit] Mechanism of action

Like all combined hormonal contraceptives, NuvaRing works primarily by preventing ovulation. A secondary mechanism of action is inhibition of sperm penetration by changes in the cervical mucus. Hormonal contraceptives also have effects on the endometrium that theoretically could affect implantation, however no scientific evidence indicates that prevention of implantation actually results from their use.[20] NuvaRing should not be used if a woman is pregnant. There is however no known harm to the woman, the course of her pregnancy, or the fetus if NuvaRing is accidentally used during pregnancy.[21]

NuvaRing delivers 120 µg of etonogestrel (a progestin) and 15 µg of ethinyl estradiol (an estrogen) each day of use.

[edit] References

  1. ^ FDA (2001). NuvaRing NDA 21-187 Correspondence Part 1, p. 8. Retrieved on 2007-04-12.
  2. ^ Organon (July 16, 2002). NuvaRing world's first vaginal birth control ring, first launch now in the US. Retrieved on 2007-04-12.
  3. ^ Organon (March 21, 2007). NuvaRing now available for Australian women. Retrieved on 2007-04-12.
  4. ^ Organon (September 15, 2005). NuvaRing is effective and well tolerated in extended use - Most women would like to decrease their number of periods a year. Retrieved on 2007-04-12.
  5. ^ Miller L, Verhoeven CH, Hout J (2005). "Extended regimens of the contraceptive vaginal ring: a randomized trial". Obstet Gynecol 106 (3): 473–82. PMID 16135576. 
  6. ^ Barreiros FA, Guazzelli CA, de Araujo FF, Barbosa R (2007). "Bleeding patterns of women using extended regimens of the contraceptive vaginal ring". Contraception 75 (3): 204–8. doi:10.1016/j.contraception.2006.10.009. PMID 17303490. 
  7. ^ a b Organon. NuvaRing: Questions patients may have: Will NuvaRing fall out?. Retrieved on 2007-04-12.
  8. ^ a b c d e Organon (August 2005). NuvaRing - US Prescribing Information. Retrieved on 2007-04-12.
  9. ^ a b Hatcher, Robert A.; Nelson, Anita (2004). "Combined Hormonal Contraceptive Methods", in Hatcher, Robert A. et al. (eds.): Contraceptive Technology, 18th rev. ed., New York: Ardent Media, pp. 391-460. ISBN 0-966-49025-8. 
  10. ^ a b c d Dieben TO, Roumen FJ, Apter D (2002). "Efficacy, cycle control, and user acceptability of a novel combined contraceptive vaginal ring". Obstet Gynecol 100 (3): 585–93. doi:10.1016/S0029-7844(02)02124-5. PMID 12220783. 
  11. ^ Organon. NuvaRing: Questions patients may have: Will my partner or I feel NuvaRing?. Retrieved on 2007-07-16.
  12. ^ Organon. NuvaRing: Knowing the benefits: Low dose of hormones. Retrieved on 2007-04-12.
  13. ^ van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC (2005). "Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive". Contraception 72 (3): 168–74. doi:10.1016/j.contraception.2005.03.005. PMID 16102549. 
  14. ^ a b Speroff, Leon; Darney, Philip D. (2005). "Vaginal and Transdermal Estrogen-Progestin Contraception", A Clinical Guide for Contraception, 4th ed., Philadelphia: Lippincott Williams & Wilkins, pp. 153-164. ISBN 0-781-76488-2. 
  15. ^ FDA (2001). NuvaRing NDA 21-187 Medical Review Part 2 pp. 51, 53. Retrieved on 2007-09-14.
  16. ^ a b Organon. NuvaRing: Questions patients may have: What are the side effects associated with NuvaRing?. Retrieved on 2007-09-14.
  17. ^ Organon. NuvaRing: Questions patients may have: Does NuvaRing cause weight gain?. Retrieved on 2007-09-14.
  18. ^ Bjarnadóttir RI, Tuppurainen M, Killick SR (2002). "Comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel/ethinyl estradiol". Am J Obstet Gynecol 186 (3): 389–195. doi:10.1067/mob.2002.121103. PMID 11904596. 
  19. ^ Cotton, Mark. "Schering-Plough, Akzo Nobel sued over NuvaRing contraceptive device", Thomson Financial News, Forbes.com, 2008-03-20. Retrieved on 2008-05-06. 
  20. ^ Rivera R, Yacobson I, Grimes D (1999). "The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices". Am J Obstet Gynecol 181 (5 Pt 1): 1263–9. doi:10.1016/S0002-9378(99)70120-1. PMID 10561657. 
  21. ^ WHO (2004). "Combined injectable contraceptives, patch & ring", Medical eligibility criteria for contraceptive use, 3rd ed., Geneva: Reproductive Health and Research, WHO. ISBN 92-4-156266-8. Retrieved on 2007-04-12. 

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