Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
Valette (Bayer Schering Pharma)
2 mg dienogest/30 microgram ethinyloestradiol tablets
(Valette contains 21 active tablets and 7 placebo tablets)
Approved indication: contraception
Australian Medicines Handbook section 17.1.1
Dienogest adds to the choice of progestogens available in combined fixed dose contraceptive pills. The combination with ethinyloestradiol has been available in Europe for several years and has been assessed in published post marketing studies.
In one study there were 11 unplanned pregnancies during 92 146 treatment cycles with the combination. Although irregular bleeding occurred in the first few cycles, 2% of women per cycle reported no withdrawal bleeds. Approximately 4% stopped treatment because of menstrual irregularities. Adverse reactions, including breast pain, weight gain and headache resulted in 3% of the women stopping treatment.1
Other adverse events include thrombosis, hypertension and alopecia. The contraindications resemble those of other oral combined contraceptive pills.
Open studies confirm that the combination is an effective contraceptive, but it is difficult to judge if it has any advantages over other combined pills. Dienogest has an antiandrogenic action, so it may have a beneficial effect on the skin of some women with acne.
- Zimmermann T, Dietrich H, Wisser K-H, Hoffman H. The efficacy and tolerability of Valette: a post marketing surveillance study. Eur J Contracept Reprod Health Care 1999;4:155-64.