New drugs

Some of the views expressed in the following notes on newly approved products should be regarded as tentative, as there may have been limited published data 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. As a result of fuller experience, initial comments may need to be modified. The Committee is prepared to do this. Before new drugs are prescribed, the Committee believes it is important that full information is obtained either from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Gestodene with ethinyloestradiol
Aust Prescr 1995;18:7-9

Femoden ED and Trioden ED (Schering)

Minulet ED and Triminulet ED (Wyeth Australia)

Femoden ED and Minulet ED tablets contain

gestodene 75 micrograms/ethinyloestradiol 30 micrograms

(21 tablets)

Trioden ED and Triminulet ED contain

gestodene 50 micrograms/ethinyloestradiol 30 micrograms

(6yellow or light beige tablets)

gestodene 70 micrograms/ethinyloestradiol 40 micrograms

(5 dark brown tablets)

gestodene 100 micrograms/ethinyloestradiol 30 micrograms (10white tablets)

All products are available as 28 day packs and include 7 inert tablets

Indication: contraception
Gestodene is a relatively new synthetic progestogen with a structure related to levonorgestrel. The combination of gestodene with ethinyloestradiol is contraceptive and these products are the monophasic and triphasic formulations.

Taken orally, gestodene is completely bio available. It binds to sex hormone binding globulin and is eliminated by metabolism. Most of the metabolites are excreted in the urine.

If gestodene/ethinyloestradiol tablets are taken correctly, pregnancy is unlikely to occur. Cycle control may be better than with monophasic pills containing levonorgestrel, although there have not been any comparative studies.1 Spotting occurs in 3-6% and breakthrough bleeding in approximately 1% of patients.

The metabolic effects of these products are similar to those of other combined oral contraceptives e.g. elevated triglyceride concentrations. The range of adverse effects also appears similar.

These products should be prescribed in the same way as currently available combined oral contraceptives. What practitioners need to know is whether or not gestodene has any advantage over other progestogens. Overseas information suggests that these products will be more expensive than their established competitors. Therefore, gestodene containing products may be of benefit in patients who have problems while taking other oral contraceptives.

Reference
1 . Chez RA. Clinical aspects of three new progestogens: desogestrel, gestodene and norgestimate. Am J Obstet Gynecol 1989;160:1296-300.


First published online: January - 1995