FDA Approves a One Year Vaginal Birth Control Ring

SUMMARY:  

FDA has approved the segesterone acetate and ethinyl estradiol vaginal system, a vaginal ring that provides up to one year of birth control.

Key highlights of this new contraceptive system method include 

  • Reusable donut-shaped silicone elastomer vaginal system (ring) 
  • Dosage and Strength
    • 103 mg segesterone acetate and 17.4 mg ethinyl estradiol
    • Releases on average 0.15 mg segesterone acetate and 0.013 mg ethinyl estradiol/day
  • Non-biodegradable, flexible vaginal system  
  • Placed in the vagina for three weeks followed by one week out  
  • During the one week out interval 
    • Women may experience withdrawal bleeding  
    • Can be washed with warm water and mild soap, dried with a clean cloth towel or paper towel and stored in a compact case use 
    • Does not require refrigeration prior to dispensing  
    • Can be stored in temperatures up to 30°C (86°F) 
  • Repeat schedule every four weeks for up to a year

KEY POINTS:  

Efficacy and Safety Studies  

  • Three, open label clinical trials  
    • Healthy women  
    • Ages 18 to 40 years  
    • 2-4 per 100 women may get pregnant during the first year of use 

Risks  

  • Boxed warning 
    • Should not be used by women > 35 years who smoke  
    • Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use

Contraindications 

  • High risk of arterial or venous thrombotic diseases 
  • Current or history of breast cancer or other estrogen- or progestin-sensitive cancer 
  • Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis 
  • Undiagnosed abnormal uterine bleeding 
  • Hypersensitivity to any of the components  
  • Use of Hepatitis C drug combinations containing ombitasvir/ paritaprevir/ ritonavir, with or without dasabuvir

Side Effects 

  • Common side effects (similar to other hormonal contraceptives)  
    • Headache/migraine 
    • Nausea/vomiting 
    • Yeast infection 
    • Abdominal pain 
    • Dysmenorrhea  
    • Breast tenderness 
    • Irregular bleeding 
    • Diarrhea  
    • Genital itching 
  • Postmarketing studies will assess additional risks for VTE and drug interactions (CYP3A modulating drugs)

Learn More – Primary Sources:  

FDA approves new vaginal ring for one year of birth control

FDA: Highlights Of Prescribing Information for Annovera

Common Medications Classified as Weak, Moderate and Strong Inhibitors of CYP3A4

FDA Drug Trial Snapshot: ANNOVERA