Zoely: combined oral contraceptive containing new progestogen

Zoely is the first combined oral contraceptive to use nomegestrol as its progesterone component.

Zoely is taken continuously, in 28-day cycles consisting of 24 active therapy days followed by 4 placebo days.
Zoely is taken continuously, in 28-day cycles consisting of 24 active therapy days followed by 4 placebo days.

PHARMACOLOGY

Zoely is a combined oral contraceptive containing nomegestrol acetate, a highly selective progestogen, and estradiol, a natural oestrogen. Nomegestrol acetate has no oestrogenic, androgenic, glucocorticoid or mineralocorticoid activity.1

CLINICAL STUDIES

The safety and efficacy of the estradiol/nomegestrol combination were assessed in two open-label phase III trials, one conducted in Europe and one performed in the US. Participants were randomised to receive 1.5mg estradiol/2.5mg nomegestrol acetate or 30 microgram ethinylestradiol/3mg drospirenone (Yasmin).1

Results

In women aged ≤35 years in the European trial (n=1,757), Pearl Indices (pregnancies per 100 woman-years) were:

  • 0.38 (95% CI 0.10–0.97) for estradiol/nomegestrol, compared with
  • 0.81 for ethinylestradiol/drospirenone (95% CI 0.17–2.35).2

In the US study, Pearl Indices in the same age group (n=1,838) were 1.27 (95% CI 0.66–2.22) and 1.89 (95% CI 0.69–4.11), respectively.3

Safety profile

The estradiol/nomegestrol combination was well tolerated in both studies, with acne and irregular withdrawal bleeding the most common adverse effects.1–3

References

  1. Zoely Summary of Product Characteristics, August 2012.
  2. Mansour D et al. Eur J Contracept Reprod Health Care 2011; 16; 430–43.
  3. Westhoff C et al. Obstet Gynecol 2012; 119: 989–999.

View Zoely drug record
 
Further information: Merck Sharp & Dohme Ltd

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