Dienogest/Estradiol Valerate

Estroprogestins with "natural oestrogen" has represented a new option in terms of combined hormonal contraception. So, the aim of this study is to investigate how estroprogestins with natural estrogen may modify the vaginal niche. In literature, very few studies focused on the interaction between hormonal contraception and vaginal milieu. This is a prospective comparative study. We enrolled 60 women from January 2013 to September 2013, 30 of them were administered estradiol valerate dienogest (E2V+DNG - Klaira®) in a quadriphasic regimen, while the other 30 women were administered 17-β estradiol with nomestrol acetate (EV+NOMAC - Zoely®) in a monophasic regimen. After a baseline study of vaginal milieu at recruitment of patients (Gram stain with Nugent score, vaginal pH, vaginal wet mount for the quantification of leukocytes, Lactobacilli and/or presence of Candida), we performed the same follow-up after six months of estroprogestin therapy. Our results showed that the women treated with E2V+DNG had a trend of an improvement of vaginal health in terms of increase of lactobacillar flora and reduction of vaginal pH in place of women treated with EV+NOMAC that showed a reduction of cervical mucus. Finally, our data about the effects on vaginal flora exerted by two estroprogestin pills (EPs) containing a natural estrogen suggest slight, but interesting differences in terms of vaginal ecology. These differences could be related to the type of estrogen, type of progestin, regimen of administration and, after all, to the net balance between estrogenic and progestin component of the EPs.

▼Zoely is the second estradiol-containing oral contraceptive formulated as an ‘extended regimen’ (pill-free interval <7 days) to be licensed in the UK. However, unlike the quadraphasic estradiol-containing contraceptive Qlaira, it is a monophasic preparation.1,2 It is postulated that combined oral contraceptives (COCs) containing synthetic estradiol, which is structurally identical to endogenous oestrogen,3 are potentially safer and better tolerated than those containing ethinylestradiol, the synthetic oestrogen most commonly used in COCs.4 The progestogen in Zoely is nomegestrol acetate, which is structurally related to progesterone,5 in contrast to the majority of progestogens in COCs that are derived from 19-nortestosterone6 and associated with androgenic effects.7 It is suggested that nomegestrol acetate, with its greater specificity for progesterone receptors, may minimise the potential for androgenic, oestrogenic and glucocorticoid effects.7 The company considers Zoely an option for women “who want a contraceptive with hormones similar to her own”, and claims that it has a high level of contraceptive efficacy, produces shorter, lighter periods compared with a 21-day regimen of drospirenone 3mg/ethinylestradiol 30µg (Yasmin) and that most women report no negative impact on weight and skin.8 Here we review the effectiveness and place of Zoely.