Study: Lack Of Efficacy Of Finasteride In Postmenopausal Women With Androgenetic Alopecia
This first study, performed in Portugal and published in 2000, consisted of 137 postmenopausal women with diagnosed AGA .
The study was carried out over one year, and it can be classified as a double-blind, placebo-controlled, randomized, multicenter trial.
The women were split into two groups, of which one received a daily dose of 1mg finasteride and the other received a placebo. This continued for 12 months, and the methods used for evaluation included:
- Scalp hair counts
- Assessment of global photographs by a blinded expert panel
- Histologic analysis of scalp biopsy specimens
How did the women fare?
According to the study, after 1 year of therapy, there was no significant difference in the change in hair count between the finasteride and placebo groups. In fact, both groups showed significant decreases in hair count in the frontal/parietal scalp.
Even further, the scalp biopsy analysis did not demonstrate any improvement in slowing hair thinning, increasing hair growth, or improving the appearance of the hair.
This study very clearly demonstrated that the women did not benefit from finasteride therapy, but a few later studies say otherwise.
Finasteride Linked To Higher Risk Of Breast Cancer In Males
Breast cancer is one of the severe side effects of Finasteride. Numerous male individuals have reported breast cancer after being given these drugs for treating either BPH or hair loss. We have commonly heard about female breast cancer, but the same disease occurring in males is quite rare and accounts for 0.6% of all breast cancers.
According to the World Standard Population, this disease’s incidence rate from the year 1995 to 2014 is
0.5 percent per 100,000 person-yearsin the Nordic countries. There had been a critical increase in male breast cancer patients after 2008. A disease survey in 2009 showed that 50 males from all over the globe werediagnosed with male breast cancer after using 5 mg of Finasteride.
A prospective link has been observed between the higher rate of MBC and the usage of Finasterides. Clinical data and cases reported in the past years give evidence of men developing cancer due to it.
Polar Views On Finasteride Use
The public needs to understand there are many views among physicians on finasteride. There are some physicians that will never prescribe this medication to women – period. There are some physicians who will prescribe it only to post-menopausal women. There are some who will prescribe to some pre-menopausal and some post-menopausal women – but only on a case by case basis – and only with full counselling of risks and benefits.
Much of the concern around use of finasteride in pre-menopausal women stems from the significant harm that would come to any fetus that was born to to a mother who used finasteride during pregnancy. These risks and real – and serious. Finasteride is given the highest category of risk during pregnancy – so called “category X.” Women who are pregnant or who could become pregnant must never use finasteride.
The other concern that some physicians have pertains to cancer risk. To date, we actually don’t have any good evidence to suggest that finasteride increases a woman’s risk of cancer. In fact, reasonably well conducted studies in men would suggest that breast cancer risk is not increased. Good studies have not been done in women. However, women with strong histories of estrogen dependent cancers should also review use of finasteride with their doctors. In some cases, use may not be appropriate. I’ll discuss other side effects below.
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Side Effects Of Finasteride
Finasteride still has side effects, however. Clinical trials indicate that men who take Finasteride might suffer from a number of sexual side effects, including:
- Loss of sex drive/ decreased libido
- Erectile dysfunction
Notably, Finasteride side effects tend to fade and disappear entirely once the drug is no longer taken. In a 2012 study, researchers at Johns Hopkins University found that the negative side effects of Finasteride might persist long after use is discontinued. That study was conducted with Propecia®, specifically, and it is important to note that the sample size was very small, consisting of fewer than 100 subjects. Follow-up studies are needed to assess the danger of long-term side effects.
For more information, readers are invited to visit our What is Finasteride reference.
Endocrine Therapies Used In Breast Cancer
Breast cancers can be hormone responsive , human epidermal growth factor 2 responsive, or triple negative for hormones or HER2. High levels of estrone and testosterone have been associated with an elevated risk of breast cancer . B-estradiol works via binding to the estrogen receptors , ER and ER, found in the mammary gland, activating cell growth. ER is present in about 4070% of breast cancers and is thought to be predictive of ET responsiveness . Approximately 2/3 of breast cancer cells express aromatase, which functions to convert androgens to aromatic estrogens .
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Review Of Data About Male Breast Carcinoma Occurring In Patients Receiving Finasteride
As of November 2009, there have been 50 worldwide case reports of male breast cancer in BPH patients aged between 54 and 88 years , who received 5 mg finasteride. The time to onset could be estimated in 35 of the reports a mean time to onset being approximately 44.4 months from the commencement of treatment. The median time to onset was 36 months . Twenty-seven cases occurred after finasteride treatment for a minimum of 1 year. Three cases have been reported with the use of Propecia® 1 mg for androgenetic alopecia. Of the 3 cases of male breast cancer reported with Propecia® 1 mg, inadequate information and the relatively short times to onset in these cases makes the causal association between male breast cancer and finasteride unlikely.
What Are The Side Effects Of Finasteride In Women
I’m often asked about the range of side effects that are possible for women who use finasteride. Side effects of finasteride in women include, but are not limited to: harm to a fetus , fatigue, weight gain, depression, anxiety, decreased libido, sexual dysfunction, hair shedding, breast tenderness, breast enlargement. Other side effects can occur but are less common. These include changes in platelet counts and muscle injury .
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Finasteride For Women: The Scientific Evidence
Since 1997, finasteride has been used exclusively in men for the treatment of AGA. However, the drug has yet to be approved for use by women who are suffering from the same condition.
The main reason for this is that finasteride is classified as a Category X drug which means it has high potential to cause serious harm to fetuses. As such, use in women of child-bearing age is extremely risky, and the benefits dont outweigh the negatives.
While studies have been performed on the use of finasteride in pre-menopausal women, the caveat is that these women were also on an oral contraceptive . Therefore, there is no way to prove that finasteride alone was responsible for the results seen.
But those arent the only studies to have been performed.
Studies performed on postmenopausal women are also available for review, and these offer a more in-depth look at the effects of finasteride on female-pattern alopecia.
Finasteride And Breast Cancer
“You should promptly report to your doctor any changes in the breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.”
Funkymonk1 said:Ther’s been some new information in Finasteride patient leaflet that got me a bit worried – “You should promptly report to your doctor any changes in the breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.”WTF, I was always given the impression that finasteride was a relatively safe drug and the really serious sides such as cancer and dementia were just scare mongering and lies. However it’s there now in black and white in the actual patient leaflet even Meric have admitted it. True, the leaflet doesn’t give the chances of getting breast cancer but even if it’s a small % is my hair really worth the chance of getting something life threatening?
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Risk Of Cancer In Men Treating Hair Loss Specifically Propecia
A review of the literature in the Journal of Drugs in Dermatology reveals a risk for increased incidence of breast cancer in men treating hair loss with systemic drugs .
A short history lesson is in order. Somewhere in the bible vaguely residing in the poorly recalled parts of my memory there was a fellow named Samson, whose strength were embodied in the length of his considerable scalp hair. When Delilah cut off his hair, he was left powerless and the rest of the story recounting his revenge is probably known to you. Suffice it to say, only when he was able to re-grow his hair could he again assert himself as a man. As history recounts, men ever-after have considered scalp hair a sign of their manhood and by extension virility, ignoring its other implications of boyishness and perhaps immaturity. Women have likewise accepted scalp hair as a sign of feminine attractiveness, power, and sensuality.
Aside from the obvious cautions for this drug, we are again faced with the paradigm that there is simply no such thing as a free lunch. Or to quote a satirist of the 1960s, Tom Lehrer, Life is like a sewer. What you get out of it depends on what you put into
National Institutes Of Health Study
A study sponsored by the National Institutes of Health followed 3,047 men as they patients were split into four groups and given medications. One group received both finasteride and doxazosin . Group 2 received finasteride alone. Group 3 received only doxazosin. The final group acted as the placebo group and given a sugar pill.
Amongst the whole group, researchers found four cases of male breast cancer in the groups taking either finasteride or doxazosin. This doesnt seem significant, but scientifically speaking, this is an incidence rate 200 times higher than that for the general population.
Just like the JNCI study, the authors of the NIH study urged the FDA to update the warning label on Propecia to include the possibility of male breast cancer. However, the FDA has still only categorized the instances as adverse reactions and has yet to take the step to concretely warn men of their increased risk of contracting this potentially deadly disease.
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Does Finasteride Or Dutasteride Used For Enlarged Prostates Cause Male Breast Cancer
Could the 5-reductase inhibitors dutasteride and finasteride increase the risk of developing male breast cancer?
In 2012, male breast cancer was identified as a possible new risk of 5ARIs by the FDA however, a 2013 study published in the Journal of Urology1 found no evidence for a relationship between male breast cancer and finasteride and dutasteride , both of which are used to treat enlarged prostate .
The study excluded finasteride , used to treat androgenic alopecia, because previous research considered a relationship between Propecia 1mg and male breast cancer unlikely.
So how did dutasteride and finasteride become implicated in the possible development of male breast cancer?
The Hypothesized Link Between Finasteride & Dutasteride and Male Brest Cancer
Going back to 1992, researchers2 had hypothesized that an increased ratio of estrogen-to-testosterone could lead to an increase risk of male breast cancer.
Even though both finasteride and dutasteride alter the normal estrogen/testosterone balance in men, the fact that 50 individuals developed male breast cancer after starting to use a 5ARI does not constitute evidence that 5ARIs contribute to the development of male breast cancer: it is possible that these 50 individuals would have developed cancer whether or not they used a 5a-reductase inhibitor.
The Study: Male Breast Cancer and 5a-Reductase Inhibitors Finasteride and Dutasteride
Can Finasteride Be Used For Female Pattern Hair Loss
Now that weve considered the scientific data, its time to answer the big question: can finasteride be used for female pattern hair loss?
The answer, unfortunately, is unclear.
As stated previously, finasteride works by inhibiting the activities of 5AR which is why the drug works so well in men with AGA. However, not all women with AGA have high androgen levels and, because of this, it makes sense that they wouldnt respond to the treatment.
But thats not to say that positive results arent possible.
As highlighted by the three studies above, there is proof that an oral daily dose of finasteride may contribute to decreased hair loss and increased hair growth. However, further research is needed to determine which dose is most effective with the least risk of side effects.
It would also be helpful to see longer-term studies on pre-menopausal women which take into account the possible benefits of oral contraceptive. The researchers could then filter the results more effectively so as to improve the transparency of the results.
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There Are Alternatives To Finasteride
Its not a treatment for everyone, especially those who are or who may become pregnant.
A few of the potential alternatives to finasteride include:
1. Spironolactone
Used to treat a wide range of conditions from heart failure to acne, Spironolactone has shown effectiveness as a hair loss medication. Its a potent anti-androgen i.e. it helps block the hormone that causes pattern hair loss in women.
2.Birth Control Pills
Another popular option, particularly among younger women, a number of oral contraceptives can help treat hair loss. The brands Yaz and Yazmin were found to be particularly effective, according to the ISHRS .
3. Hormonal therapy
Estrogen and progesterone are frequently used to combat female hair loss. This combined treatment approach is sometimes known as hormonal therapy.
Who Can And Cannot Use Finasteride
Finasteride can be taken by men aged 18 years or over.
It’s generally not recommended for women or children.
Finasteride is not suitable for some people. To make sure this medicine is safe for you, tell a doctor if you:
- have had an allergic reaction to finasteride or any other medicines in the past
- have severe bladder problems
- have liver problems
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Study: Finasteride Treatment Of Patterned Hair Loss In Normoandrogenic Postmenopausal Women
A 2004 study performed in Switzerland tested the effects of 2.5mg and 5mg finasteride on five postmenopausal women over a span of 18 months .
The efficacy of the drug was evaluated by patient and investigator assessments, as well as a review of photographs taken at baseline and at months six, 12 and 18 by an expert panel.
As the results of this study indicate, the 2.5mg dose of finasteride was enough to decrease hair loss, increase hair growth, and improve the appearance of hair within 18 months of use. Even further, there were no adverse effects reported.
Do keep in mind that assessments were subjective and, as such, cannot be held up as proof of finasterides positive effects on pattern loss in women. In addition, the sample size was quite small.
Fortunately, there is another more recent study with an objective study design.
Mechanism Of Finasteride In Female Pattern Hair Loss
Because FPHL is a complex disease, the mechanism by which finasteride improves hair loss is not well established. A study in mice proposed that DHT may downgrade insulin-like growth factor-1 expression by inhibiting the release of calcitonin gene-related peptide that interacts with the androgen receptors, thereby preventing hair growth.39 These findings suggested that finasteride might be associated with increasing IGF-1 production in the dermal papillae by decreasing DHT levels.40 Rushton et al found that finasteride administration resulted in increased mean hair density without insignificant changes of vellus hair counts.41 The observed hair regrowth in FPHL may be supported by reactivating telogen/kenogen follicles into anagen follicles rather than vellus-to-terminal hair transformation. Further studies are needed to determine the mechanism of finasteride in FPHL. Concerning contradictory efficacy in pre-existing literatures, oral finasteride may be served as an alternative modality in FPHL patients who fail minoxidil treatment. We suggest using finasteride in postmenopausal women to avoid potential teratogenic effects.
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Sexual Side Effects Are Most Common
A 2018 report with 236 patients the largest Im aware of focused primarily on the safety of the medication.
After 3 months, 25% of users reported reduced libidos.
That side effect
Headache, Sore Breasts, and Hirsuitism were a few of the other noteworthy complaints.
In the study above, 25% of patients reported an adverse effect after 3 months.
At the last evaluation, after 3 years on finasteride, the overall side effect rate was just over 3% among the patients.
Below is a adverse effect chart from that study.
Notice how the side effects decreased dramatically with time.
Does Finasteride Cause Cancer
Finasteride is known among male hair loss sufferers as a powerful prescription medication capable of ceasing hair loss. Like all prescription medicines, Propecia is not without side effects. Most know that the medication may cause sexual side effects for the men who take it regularly. But are men also at risk of developing breast cancer?
Physicians have long prescribed Finasteride, and in some cases Dutasteride, to treat symptoms of enlarged prostate in men, or benign prostatic hypertrophy . As a 5-alpha reductase inhibitor, the medicine also helped to cease hair loss in subjects by warding off the chemical reaction that researchers believe causes hair follicles to stop producing hair. However, post-marketing data demonstrated some risk. Specifically, rare reports indicated that male breast cancer were a side effect of Finasteride treatment. For this reason, among others, Finasteride was considered dangerous to prescribe to women. Today, most hair transplant surgeons still steer women clear of Finasteride medication, recommending alternative surgical and non-surgical treatments for hair loss.
Despite rare reports of male breast cancer in men who took the popular BPH/ hair loss drug, the FDA approved Finasteride as a treatment for male pattern baldness in 1997. Now, nearly 15 years later, a study published in the Journal of Urology indicates that there is no link between Finasteride and breast cancer in men.
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