Molecular mass: 288.424 g/mol PubChem compound: 5881
Prasterone interacts in the following cases:
Concomitant use with systemic hormone replacement therapy (oestrogen-only or oestrogen-progestagen combination or androgen treatment) or vaginal oestrogens has not been investigated and is therefore not recommended.
Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with prasterone, in particular:
Prasterone is not indicated in pre-menopausal women of child-bearing age, including pregnancy.
If pregnancy occurs during treatment with prasterone, the treatment should be withdrawn immediately. There are no data on the use of prasterone in pregnant women.
No studies in animals were performed with regard to the reproductive toxicity. The potential risk in humans is unknown.
Prasterone is not indicated during breast-feeding.
Prasterone is not indicated in fertile women.
Prasterone has no influence in the ability to drive and use machines.
The most frequently observed adverse reaction was vaginal discharge. This is due to melting of the hard fat used as vehicle, added to the expected increase in vaginal secretions due to treatment. It is not required to stop prasterone if vaginal discharge occurs.
The adverse reaction observed with prasterone 6.5 mg pessaries obtained from clinical studies is tabulated below.
| MedDRA System Organ Class | Common (≥1/100 to <1/10) | Uncommon (≥1/1,000 to <1/100) |
|---|---|---|
| General disorders and administration site conditions | Application site discharge | |
| Reproductive system and breast disorders | Abnormal Pap smear (mostly ASCUS or LGSIL) | Cervical/uterine polyps Breast mass (benign) |
| Investigations | Weight fluctuation |
Million Women study– Estimated additional risk of breast cancer after 5 years' use:
| Age range (years) | Additional cases per 1000 never-users of HRT over a 5 year period1* | Risk ratio & 95% CI# | Additional cases per 1000 HRT users over 5 years (95% CI) |
|---|---|---|---|
| Oestrogen only HRT | |||
| 50-65 | 9-12 | 1,2 | 1-2 (0-3) |
1* Taken from baseline incidence rates in developed countries
# Overall risk ratio. The risk ratio is not constant but will increase with increasing duration on use.
Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
US WHI studies – additional risk of breast cancer after 5 years' use:
| Age range (yrs) | Incidence per 1000 women in placebo arm over 5 years | Risk ratio & 95% CI | Additional cases per 1000 HRT users over 5 years (95% CI) |
|---|---|---|---|
| CEE oestrogen-only | |||
| 50-79 | 21 | 0.8 (0.7–1.0) | -4 (-6 – 0)2* |
2* WHI study in women with no uterus, which did not show an increase in risk of breast cancer
Use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed.
A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
HRT is associated with a 1.3-3-fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of using HT. Results of the WHI studies are presented:
WHI Studies – Additional risk of VTE over 5 years' use:
| Age range (years) | Incidence per 1000 women in placebo arm over 5 years | Risk ratio and 95% CI | Additional cases per 1000 HRT users |
|---|---|---|---|
| Oral oestrogen-only3* | |||
| 50-59 | 7 | 1.2 (0.6 – 2.4) | 1 (-3 – 10) |
The risk of coronary artery disease is slightly increased in users of combined oestrogen-progestagen HRT over the age of 60.
The use of oestrogen-only and oestrogen + progestagen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT.
This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age.
WHI studies combined – Additional risk of ischaemic stroke4 over 5 years' use:*
| Age range (years) | Incidence per 1000 women in placebo arm over 5 years | Risk ratio and 95% CI | Additional cases per 1000 HRT users over 5 years |
|---|---|---|---|
| 50-59 | 8 | 1.3 (1.1-1.6) | 3 (1-5) |
4* no differentiation was made between ischaemic and haemorrhagic stroke.
Other adverse reactions have been reported in association with oestrogen/progestagen treatment:
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