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References

 

  1. FDA approves Natazia for heavy menstrual bleeding [press release]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; March 14, 2012. https://www.drugs.com/newdrugs/u-s-fda-approves-first-only-oral-contraceptive-demonstrated-heavy-menstrual-bleeding-hmb-3150.html. Accessed March 29, 2019. 
  2. Endrikat J, Parke S, Trummer D, Schmidt W, Duijkers I, Klipping C. Ovulation inhibition with four variations of a four-phasic estradiol valerate/dienogest combined oral contraceptive: results of two prospective, randomized, open-label studies. Contraception. 2008;78(3):218-225.
  3. Natazia—a new oral contraceptive. Med Lett Drugs Ther. 2010;52(1346):71-72.
  4. Rafie S, Borgelt L, Koepf ER, Temple-Cooper ME, Lehman KJ. Novel oral contraceptive for heavy menstrual bleeding: estradiol valerate and dienogest. Int J Womens Health. 2013;5:313-321.
  5. Nelson A. New low-dose, extended-cycle pills with levonorgestrel and ethinyl estradiol: an evolutionary step in birth control. Int J Womens Health. 2010;2:99-106.
  6. Mayo Clinic. Birth control pill FAQ: benefits, risks and choices. https://www.mayoclinic.org/healthy-lifestyle/birth-control/in-depth/birth-control-pill/art-20045136. Updated May 25, 2019. Accessed August 13, 2019.
  7. Ahrendt H-J, Makalová D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009;80(5):436-444.
  8. Data on file. CSR A35644. Bayer HealthCare Pharmaceuticals Inc; Whippany, NJ. 
  9. Fraser IS, Römer T, Parke S, et al. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind phase III trial. Hum Reprod. 2011;26(10):2698-2708.
  10. Jensen JT, Parke S, Mellinger U, Machlitt A, Fraser IS. Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest: a randomized controlled trial. Obstet Gynecol. 2011;117(4):777-787.

Important Safety Information

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Women over 35 years old who smoke should not use Natazia. Smoking increases the risk of serious cardiovascular side effects from Natazia use. This risk increases with age and the number of cigarettes smoked.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. 

 

For Bayer products, you can report these directly to Bayer by clicking here. 

 

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