Ethinylestradiol/etonogestrel
Combination of | |
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Ethinylestradiol | Estrogen |
Etonogestrel | Progestogen |
Clinical data | |
Trade names | NuvaRing, others |
AHFS/Drugs.com | Monograph |
MedlinePlus | a604032 |
License data | |
Vaginal (ring) | |
ATC code |
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Legal status | |
Legal status |
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Identifiers | |
CAS Number | |
PubChem CID | |
ChemSpider |
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KEGG |
Ethinylestradiol/etonogestrel, sold under the brand names NuvaRing among others, is a
Common side effects include
The combination was approved for medical use in the United States in 2001.
Medical use
The ring is placed into the
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 birth control ring periodically with their finger. In rare instances, NuvaRing may fall out during sexual intercourse, while straining before or during a bowel movement, or while removing a tampon.[10][11]
In the case of accidental expulsion, the manufacturer recommends rinsing the ring with lukewarm water before reinserting. If not done correctly, the risk of pregnancy is increased. Birth control efficacy is reduced if the ring is removed, accidentally expelled, or left outside of the vagina for more than three hours. If left outside of the vagina for more than three hours, the device is to be rinsed and reinserted immediately. If this occurs, the manufacturer recommends that a backup method of birth control be used until the ring has been used continuously for a subsequent seven days.[10][11]
Benefits
The benefits of the ring include:
- once-a-month self-administered use offering convenience, ease of use and privacy (most users and most partners do not feel the ring, and of those who do, most do not object to it)[12][13][14]
- lower estrogen exposure than with combined oral contraceptive pills or the contraceptive patch Ortho Evra.[12][15][16]
- a low incidence of estrogenic side effects such as
- a low incidence of
Contraindications
The contraceptive vaginal ring is contraindicated for a risk of blood clots. This is because it contains the hormone etonogestrel, the active metabolite of the prodrug desogestrel. It is a third-generation contraceptive.[18]
A study in The BMJ, with over 1.6 million women, found that users of vaginal rings with ethinylestradiol and etonogestrel have a 6.5 times increased risk of venous thrombosis compared to non-users.[19][20] Epidemiological studies have shown that oral contraceptives that contain desogestrel can increase the risk of blood clots (venous thrombosis) by 1.5 to 2.4 times the risk of second-generation oral contraceptives.[21] Second-generation oral contraceptives do not contain desogestrel. Hormones are released continuously from NuvaRing, thus peak and total estrogen and progestin doses are lower than with combined oral contraceptives, but what effect this has on the risk of blood clots has not been established.[11]
NuvaRing also has the
NuvaRing should not be used while
Side effects
In two large studies, over a one-year period, 15.1% of users discontinued NuvaRing because of adverse events. Device-related adverse events (foreign object sensation, sexual problems, 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.[13]
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%), weight gain (4.9%) and hair loss .[11][23][24]
NuvaRing is weight neutral.[25][26]
Additional side effect information (including, but not limited to, severe blood clots) is provided in the NuvaRing full prescribing information.
Blood clots
The vaginal ring with ethinylestradiol and etonogestrel increases the risk of
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.[29] NuvaRing should not be used if a woman is pregnant.
NuvaRing delivers 120 µg of
Society and culture
Restrictions on use
In July 2014, CTV News reported that Merck Canada Inc. stated that women who are over 35 and smoke should not use the NuvaRing. In addition to this group of women, women who have any of the following conditions also should not use the NuvaRing: abnormal blood-fat levels, clotting disorders, diabetes, heart disease, high blood pressure, migraine headaches with vision problems or "constant stomach pain caused by pancreatic dysfunction along with high levels of fats in the blood".[30]
Lawsuits
Lawsuits were filed in the US against Merck alleging it concealed health risks associated with the product.[18] These were settled for $100 million in 2014.[31]
In March 2008, the first lawsuit was filed against the manufacturers, distributors, and marketers of NuvaRing. The plaintiff alleged that these companies concealed the health risks associated with using the device, which is claimed to have caused the death of the plaintiff's wife.[32] Subsequent plaintiffs alleged multiple problems with the advertising of NuvaRing and that they downplayed its risks of injury and death.[33] The company denied these allegations.[33]
The first
History
NuvaRing was first approved in The Netherlands in February 2001, then by the European Union in June 2001, and in the United States by the US Food and Drug Administration (FDA) in October 2001.[39][40]
NuvaRing was first marketed in the United States in July 2002,[41] followed by a number European countries since then.[42]
Research
A study by Danish researcher Dr. Øjvind Lidegaard in 2012 with 1.6 million women found a 6.5 times increase in the likelihood of venous thromboembolism when compared to users of non-hormonal based birth control. In Canada, Lidegaard's study led to a change in labeling warning of increased risk of blood clots, but not in the United States.[20]
See also
- Combined injectable contraceptive
- Contraceptive patch
- Oral contraceptive formulations
- List of combined sex-hormonal preparations
References
- ^ ISBN 9780857113382.
- ^ a b "Ethinyl Estradiol and Etonogestrel (Professional Patient Advice)". Drugs.com. Retrieved April 19, 2019.
- OCLC 781956734. "Table 3–2 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" (PDF). Archived from the original(PDF) on February 15, 2017.
- ^ a b c d e f g "NuvaRing - FDA prescribing information, side effects and uses". Drugs.com. Retrieved April 19, 2019.
- ^ "The Top 300 of 2021". ClinCalc. Archived from the original on January 15, 2024. Retrieved January 14, 2024.
- ^ "Ethinyl Estradiol ; Etonogestrel - Drug Usage Statistics". ClinCalc. Retrieved January 14, 2024.
- ^ "NuvaRing is effective and well tolerated in extended use - Most women would like to decrease their number of periods a year". Organon. September 15, 2005. Archived from the original on October 18, 2006. Retrieved April 12, 2007.
- S2CID 46164922.
- PMID 17303490.
- ^ Organon. "NuvaRing: Common Questions: Will NuvaRing fall out?". Archived from the originalon July 6, 2012. Retrieved July 6, 2009.
- ^ (PDF) on March 23, 2007. Retrieved April 12, 2007.
- ^ ISBN 978-0-9664902-5-1.
- ^ S2CID 23769913.
- Organon. "NuvaRing: Questions patients may have: Will my partner or I feel NuvaRing?". Archived from the originalon February 25, 2007. Retrieved July 16, 2007.
- Organon. "NuvaRing: Knowing the benefits: Low dose of hormones". Archived from the originalon November 18, 2006. Retrieved April 12, 2007.
- PMID 16102549.
- ^ ISBN 978-0-7817-6488-9.
- ^ a b Mencimer S (2009). "Is NuvaRing Dangerous?". Mother Jones. Retrieved June 30, 2013.
- ^ PMID 22577198.
- ^ The Huffington Post. Retrieved December 19, 2013.
- ^ Walker MB, Bussey HI (2007). "Should 3rd Generation Birth Control Pills be Banned? - Petition to Ban 3rd Generation OCs due to Increased Clotting Risk". Archived from the original on September 13, 2008. Retrieved September 30, 2008.
- ^ "emedtv.com". Archived from the original on March 4, 2016. Retrieved December 28, 2016.
- ^ FDA (2001). "NuvaRing NDA 21-187 Medical Review Part 2" (PDF). Food and Drug Administration. pp. 51, 53. Archived from the original (PDF) on September 26, 2007. Retrieved September 14, 2007.
- ^ Organon. "NuvaRing: Questions patients may have: What are the side effects associated with NuvaRing?". Archived from the originalon October 25, 2008. Retrieved September 14, 2007.
- Organon. "NuvaRing: Questions patients may have: Does NuvaRing cause weight gain?". Archived from the originalon October 25, 2008. Retrieved September 14, 2007.
- PMID 11904596.
- PMID 18728840.
- ^ PMID 19679614.
- PMID 10561657.
- ^ "NuvaRing maker advises some women to avoid using product". The Canadian Press. CTV News. July 31, 2014. Retrieved August 8, 2014.
- ^ "Merck to Dole Out $100 Million in NuvaRing Settlement". Time. February 7, 2014. Retrieved April 19, 2019.
- ^ Cotton M (March 20, 2008). "Schering-Plough, Akzo Nobel sued over NuvaRing contraceptive device". Forbes. Thomson Financial News. Archived from the original on March 30, 2008. Retrieved May 6, 2008.
- ^ a b Edwards J (April 19, 2014). "At Merck, an Undercover Video and 40 Deaths Plague Nuvaring Birth Control Brand". CBS News. Archived from the original on March 10, 2014. Retrieved June 5, 2014.
- ^ "Case: 4:08-md-01967-RWS (Nuvaring Products Liability Litigation)" (PDF). Retrieved November 22, 2013.
- ^ a b "NuvaRing's $100 Million Settlement Deadling is Monday", The Detroit Free Press, March 9, 2014, page 9A
- ^ "Merck to settle NuvaRing lawsuits for $100 mln -media report". Reuters. February 6, 2014. Retrieved February 7, 2014.
- ^ Feeley J, Voreacos D (February 7, 2014). "Merck to Pay $100 Million NuvaRing Pact If Women Join". Forbes. Thomson Financial News. Retrieved February 6, 2014.
- ^ Salter J (June 5, 2014). "$100 Million NuvaRing Settlement Finalized". ABC News. Archived from the original on June 5, 2014. Retrieved June 5, 2014.
- ^ Doyle J (March 1, 2014). "FDA approved NuvaRing despite experts' safety concerns". St. Louis Post-Dispatch. Retrieved March 11, 2014.
- Food and Drug Administration (United States) (2001). "NuvaRing NDA 21-187 Correspondence Part 1" (PDF). Food and Drug Administration. p. 8. Archived from the original(PDF) on September 26, 2007. Retrieved April 12, 2007.
- Organon (July 16, 2002). "NuvaRing world's first vaginal birth control ring, first launch now in the US" (PDF). Archived from the original(PDF) on November 30, 2006. Retrieved September 14, 2008.
- ^ "Organon's Once-a-Month Contraceptive Ring, NuvaRing(R) Completes European Authorization". PR Newswire. Retrieved June 30, 2013.