What is the usage and recommendation for Zoely (estradiol and nomegestrol acetate) tablets as a contraceptive method?

Zoely (Nomegestrol Acetate/Estradiol) Contraceptive Tablets

Zoely is a highly effective monophasic combined oral contraceptive containing nomegestrol acetate (NOMAC) 2.5mg and 17β-estradiol (E2) 1.5mg that should be taken in a 24/4-day regimen (24 active pills followed by 4 placebo pills) with excellent contraceptive efficacy and favorable safety profile. 1, 2, 3

Composition and Unique Features

• First monophasic combined oral contraceptive containing natural 17β-estradiol instead of ethinyl estradiol 4
• Contains nomegestrol acetate (NOMAC), a highly selective progestogen derived from 19-norprogesterone 5
• Administered in a 24/4 regimen (24 active tablets followed by 4 placebo tablets) 2

Efficacy

• Pearl Index of 0.38 in European studies and 1.13 in US studies, indicating high contraceptive reliability 4
• Particularly effective in overweight and obese patients 1
• High antigonadotropic activity and long elimination half-life (approximately 50 hours) help maintain contraceptive efficacy even when doses are missed 5

Safety Profile and Metabolic Effects

• Minimal impact on:

  • Hemostasis and blood clotting factors
  • Lipid profile
  • Carbohydrate metabolism
  • Blood pressure
  • Bone mineral density 1, 4

• Contains natural estradiol rather than ethinyl estradiol, which may potentially reduce thrombotic side effects typically associated with combined oral contraceptives 3

Cycle Control and Bleeding Pattern

• Provides good cycle control comparable to pills containing ethinyl estradiol 5
• Withdrawal bleedings are typically shorter and lighter compared to other combined hormonal contraceptives 2
• Approximately 30% of women experience absence of withdrawal bleeding after 12 months of use 4

Side Effects and Tolerability

• Generally well tolerated with an acceptable safety profile 2
• Most common adverse events include:
  • Acne (may be less favorable compared to some other combined pills)
  • Abnormal withdrawal bleeding (shorter, lighter, or absent periods) 2
• Minimal weight gain reported 1

Usage Instructions

• If starting Zoely or switching from another hormonal contraceptive, follow the standard recommendations for combined oral contraceptives 6

• If one pill is late (less than 24 hours since it should have been taken):

  • Take the missed pill as soon as possible
  • Continue taking remaining pills at the usual time
  • No additional contraceptive protection needed 6

• If one pill is missed (24 to <48 hours since it should have been taken):

  • Take the most recent missed pill as soon as possible
  • Continue taking remaining pills at the usual time
  • Use backup contraception for 7 consecutive days 6

• If two or more consecutive pills are missed (≥48 hours):

  • Take the most recent missed pill immediately
  • Use backup contraception until pills have been taken for 7 consecutive days
  • Consider emergency contraception if pills were missed during the first week and unprotected intercourse occurred 6

Special Considerations

• Fast recovery of ovarian activity after discontinuation makes it suitable for women planning future pregnancies 1
• In case of vomiting or severe diarrhea within 24 hours of taking a pill, follow the missed pill guidelines 6
• Like all combined hormonal contraceptives, Zoely does not protect against sexually transmitted infections 6

Caution

While Zoely has a favorable metabolic profile, it shares the same contraindications as other combined hormonal contraceptives, including history of venous thromboembolism, migraine with aura, and certain cardiovascular risk factors 4.