What is Dianette?

Dianette (Also known as Diane 35) is essentially an ethinyl oestradiol oral contraceptive pill with the antiandrogen cyproterone acetate used for the treatment of hirsutism and acne. In most respects all the advice for any combined oral contraceptive pill pertains. Dianette is used for treatment of hirsutism and acne and is not generally recommended otherwise for birth control.

What is hirsutism?

Hirsutism is characterised by excess body hair in a typically male distribution. The hair is pigmented and thick. It may be particularly obvious when it is on the moustache or beard areas. The other common sites are the chest, abdomen, thighs and back. Pubic hair growth may extend upward from the usual bikini-line to the middle of the abdomen (umbilicus) (Figure 8.1). For a woman to be hirsute is understandably embarassing.

 

Figure 8.1 Hirsutism - Excess Hair Distribution

What is cyproterone acetate?

Cyproterone acetate is an anti-androgen; it competes at the receptor sites (hormones) with androgens and reduces their effects. Androgens are male hormones and are produced by women as well as men. They stimulate the growth of the skin, including the sebaceous glands that produce oil (sebum), and the hair that grows from the skin. If your body produces too much androgen, or if your skin is particularly sensitive to the effects of androgens, the sebaceous glands may produce too much sebum. This can cause the sebaceous glands to become blocked, resulting in infection, inflammation and acne spots. The androgens may also cause excessive growth of the hair on the face and body - hirsutism. Both these problems are common in women with polycystic ovary syndrome (PCOS).

Dianette (also known as Diane 35) tablets contain two active ingredients, cyproterone acetate and ethinylestradiol. This combination of medicines is also known as co-cyprindiol. Co-cyprindiol tablets are also available without a brand name, ie as the generic medicine.

Each pack of Dianette contains three strips of 21 tablets.

Each Dianette contains the active ingredients cyproterone acetate 2mg and ethinylestradiol 35 micrograms.


Cyproterone acetate is used to prevent these actions of the androgens. It works by blocking the receptors in the body that the androgens normally work on. This means that the androgens can no longer affect the skin or the hair and acne and hirsutism can improve. Cyproterone acetate also decreases the production of androgens by the ovaries, so that there are less of these male hormones circulating.

Higher dose cyproterone acetate may be considered. It is prescribed in a 'reverse-sequential dose regimen' when there is an inadequate response to previous medication. Usually, progestogens are taken in the latter half of cyclical oestrogen therapy, in HRT for example (HRT and progestogen). Cyproterone acetate is stored in the fat tissues and when it is administered late in the cycle there is a tendency for the period to be delayed. Cyproterone acetate 50mg or 100mg is, therefore, given on the first 10 days of each course of the pill. When cyproterone acetate is given in combination with the pill, it is likely to reduce hair growth, lighten the hair colour, and decrease the hair thickness in hirsute areas. Your doctor may re quest blood tests from time to time to check hormone levels and to ensure that your chemistry is not being affected adversely. Until recently, it was believed that cyproterone pills (Dianette) carried a greater risk of being associated with thromboembolism. This no longer appears valid.2007-01

Medical treatments for hirsutism are not rapidly effective, overnight remedies. New hair follicles are developing all the time and each lasts for about three years. In one study of hirsute patients, 10-20% of patients were improving after six months and 90% were happy after 36 months. These treatments only work whilst they are being taken. They do not cure the underlying abnormality so that when treatment is discontinued the hirsutism may recur.


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What side effects could I have whilst taking Dianette?

The vast majority of patients taking Dianette feel very well but, as with any medicine that has benefits, some minor side effects are occasionally reported. These include:

  • altered body weight (some gain a few pounds and others lose a little).
  • nausea (feeling sick) and vomiting.
  • mastalgia (breast tenderness).
  • headaches (Dianette should be stopped if they become severe).
  • altered libido (sex drive - Q15.5) with many women noticing an increase and others a reduction.
  • depression.
  • reduced or absent menstrual flow (Q15.4 ;24.17A).

These side effects usually settle within two or three months.

What is the effect of birth pills on body weight?

All of us are intermittently gaining or losing weight.

Inevitably some patients find that they gain weight around the time of starting Dianette but others observe a weight loss.

In a personal computer search of the medical literature from 1966 to date I found exactly fifty papers (articles in medical journals) where weight change in relation to Dianette had been studied.

  • Thirty-six papers indicated no change, eleven found an increase varying from 0.3kg to 2.4Kg.
  • Three papers found weight loss with the combined oral contraceptive pill for women who were overweight or who had polycystic ovaries.

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Will Dianette increase my vaginal discharge?

Cervical ectopy (erosion - cervical erosion) appears to be more common in women taking the combined oral contraceptive pill although the newer lower dose pill seem to cause this less frequently. Cervical ectopy only requires treatment if there are persistent significant symptoms after excluding other problems such as infection. Contrary to popular belief, there is no evidence that Dianette increases the incidence of candida (thrush).

Does Dianette increase my chance of pelvic infections?

There is no increase in the incidence of Candida infection in pill users. The incidence is the same as in women with intrauterine devices and those using no contraception. Bacterial infections that gain entry to the pelvis through the cervix are less common in pill users as the progestogen makes the cervical mucus thick. However, there is no protection against viruses or chlamydia.

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What is the relationship between Dianette and fibroids?

Surprisingly, studies show that the combined oral contraceptive pill reduces the chance of fibroid development. It is a surprise because both oestrogen and progesterone are factors in fibroid development so fibroids shrink after the menopause (HRT-Add-Back). The current presumption is that the total of these hormones provided by the combined oral contraceptive pill in a month must be less than the natural hormone output by the ovaries.


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Will Dianette increase my blood pressure?

For the majority of women, the blood pressure increases on the combined oral contraceptive pill by an average of 1mm Hg (a tiny amount). An increase of 5-10mm Hg may be of clinical importance but 1mm really does not matter. This is an example of a statistical (mathematical) proven increase that has no consequence from the medical point of view.

The international recommendation is that the combined oral contraceptive pill should not be started or continued if your blood pressure is 160/100 or higher. High blood pressure can be a factor in heart disease and strokes and as a few women (about 1%) may develop clinically significant raised blood pressure, checks should be carried out periodically. Your blood pressure should be measured before you start Dianette and three months later. If your blood pressure is normal it should be reviewed at six months intervals and after two years it can be reviewed annually.


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Does Dianette have any effect on the blood?

All chemicals in the blood are eventually removed and eliminated from the body. The liver plays a key role in this process and this is true for oestrogens and progestogens. The oestrogen and progestogens in the combined oral contraceptive pill results in a slight alteration in the fat chemistry of the blood. There is a rise in low-density cholesterol (Q 27.4) and triglycerides and a reduction of high-density cholesterol. These changes have been reduced by the more modern pills.

When we cut ourselves a blood clot forms to seal the wound and stop the bleeding.

  • This involves a cascade of chemical reactions in the blood that lead to the clot forming.
  • Some people are particularly prone to inappropriate blood clots, which occur within the veins usually in the legs or pelvis.
  • If such a blood clot, which is called a deep venous thrombosis, becomes dislodged it can travel to the lungs and causes a pulmonary embolism, which is a serious life threatening condition.
  • The combined oral contraceptive pills do have a slight adverse effect on the clotting mechanism. Again, the new low oestrogen dose preparations are less likely to lead to problems.

What is the relationship between Dianette and thromboembolism (blood clots)?

Deep venous thrombosis and pulmonary embolism are uncommon if you are young (Figure 15.1). There is a slight increased risk of these problems if you are taking a combined oral contraceptive pill and the risk is further increased for those who are overweight or who smoke. The newer and lower oestrogen dose pills probably cause fewer problems. To put the risk in context, a woman taking the combined oral contraceptive pill is more likely to be hospitalised as a result of an accident than from a complication associated with her pill.

Figure 15.1

A study by the World Health Organisation (WHO) published in 1995 provided evidence that the newer pills with their lower oestrogen content are associated with lower incidence of thromboembolism than the earlier higher oestrogen dose pills. This study also brought attention to the relationship between the progestogen in the combined oral contraceptive pill and thromboembolism.  

What is the relationship between the combined oral contraceptive pill and heart attacks?

The combined oral contraceptive pill has slight adverse effects on the lipids (“fat" chemicals) in the blood and these changes are known risk factors for heart disease. Heart attacks before the menopause are rare. Studies of patients on the early high dose preparations of the combined oral contraceptive pill found a five-fold increase in the incidence of heart attacks. Further studies demonstrated that there are usually confounding (additional) factors contributing to the attacks. In particular, smoking increases the risks. With the more modern low dose pills the risks are probably lower. The latest evidence suggests that there is no increased risk of heart attacks for oral contraceptive users.

The current recommended advice is that smokers should discontinue the combined oral contraceptive pill at the age of 35years. The best advice is that smokers should stop smoking.


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What is the relationship between Dianette and strokes?

Strokes are uncommon in young women but there is a marginal statistical increase in those who have taken the combined oral contraceptive pill. Strokes may involve haemorrhage (bleeding) within the brain or reduced blood supply (ischaemia) to part of the brain. In young women it is the bleed variety of stroke that is the more common. One study in Europe found no significant increase in the chance of the bleed variety of stroke in association with the combined oral contraceptive pill. Smoking and high blood pressure are more important risk factors and these confuse any analysis of the risks of the combined oral contraceptive pill.


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Does Dianette affect the breasts?

Many women find that their breasts are slightly larger when taking the combined oral contraceptive pill. Breast discomfort (mastalgia) may respond to vitamin B 6 (pyridoxine) 50 mg once or twice daily. Otherwise a change of pill should be considered. Should milk production occur (galactorrhoea) investigation of the prolactin hormone level is indicated (hyperprolactinaemia). Benign breast disease (Q 27.16) tends to improve when the combined oral contraceptive pill is taken.

Could I feel depressed as a result of taking Dianette?

A few women describe a little depression when taking the combined oral contraceptive pill. The pill does not cause severe depression. If a change of pill does not solve the problem, pyridoxine (Vitamin B6) 50mg daily may be beneficial but it can take up to two months to be effective.


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