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Testosterone Regulation and Autism Ranking: Mildly Hazardous Insufficient/Mixed evidence

Syringe Testosterone is an androgen hormone which regulates the development of the male reproductive system and male secondary sex characteristics (such as facial hair). 

Testosterone regulation involves using drugs called gonadotropin-releasing hormone agonists to reduce the amount of testosterone in the body. 

There are a number of gonadotropin-releasing hormone agonists, each of which is sold under a variety of brand names. For example, the drug leuprolide is sold under the brand names Prostap, Viadur, Eligard and Lupron.

Testosterone regulation is normally used to treat people with one or more medical conditions including advanced prostate cancer, precocious puberty, endometriosis or anaemia caused by uterine fibroids.

Some researchers believe that some autistic individuals have too much testosterone and an excess of heavy metals in their bodies. They believe that testosterone regulation, used alongside other treatments, can help to reduce the amount of testosterone and heavy metals in the body.

They also believe that this can lead to a decrease in the core features of autism and some challenging behaviours (such as hyperactivity/impulsivity, aggression, self-injury, severe sexual behaviours, and irritability).

Please Note

The National Institute of Health and Clinical Excellence (NICE) made the following recommendation.

'Do not use testosterone regulation for the management of core symptoms of autism in adults.' (NICE, 2012)

Our Opinion

Gonadotropin-releasing hormone agonists are very powerful drugs and are designed to change the hormonal balance in adults. Used on children or adolescents, they could cause disastrous and irreversible damage to sexual functioning.

They can also be very expensive, with some providers charging anywhere between $200-$2,000 per injection.

There is no high quality research evidence to suggest that regulating testosterone provides any benefits to autisticpeople.

For all of these reasons we believe that regulating testosterone should not be used as a treatment for autistic individuals, unless and only if it is used to treat specific medical conditions, such as prostate cancer, for which it was designed.

Disclaimer

Please read our Disclaimer on Autism Interventions


Audience

Testosterone regulation is sometimes used to treat medical conditions such as advanced prostate cancer, precocious puberty, endometriosis, or anaemia caused by uterine fibroids.*

However some researchers (such as Geier and Geier, 2006) have suggested that testosterone regulation can also be used to treat the core features of autism and challenging behaviours (such as hyperactivity/impulsivity, aggression, self injury, severe sexual behaviours, and irritability). 

*Notes: anaemia (a lower than normal number of red blood cells); precocious puberty (condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics); endometriosis (condition in which the type of tissue that lines the womb grows in other areas of the body and causes pain, heavy or irregular periods); uterine fibroids (noncancerous growths in the womb).

Aims and Claims

Aims

Gonadotropin-releasing hormone agonists are used to treat a range of conditions including advanced prostate cancer; central precocious puberty, endometriosis and anaemia caused by uterine fibroids.

However some researchers believe that many of the core features of autism and challenging behaviours are caused by excessive amounts of heavy metals in the body. They also believe that excessive amounts of androgens (the male hormone) may react with those heavy metals to make those features and behaviours worse.

For example, according to Geier and Geier, 2005, “It has previously been suggested as a medical hypothesis that some ASDs may result from interactions between the methionine cycle-transsulfuration and androgen pathways following exposure to mercury. It was suggested that children experiencing such a condition would have an elevated body-burden of heavy metals and have increased androgens. Based upon this knowledge, treatment modalities were suggested to attempt to dually lower the body-burden of heavy metals and decrease androgen levels in children with ASDs, in the hopes that addressing the steroid hormone pathways, in addition to treatments that successful lower heavy metal body burdens, would work synergistically to improve clinical outcomes.”

They go on to cite various authorities for this theory, including Professor Baron-Cohen of the Autism Research Centre. However Baron-Cohen emphatically rejects their interpretation of his work.

Claims

There have been various claims for the use of leuprolide as a way of regulating testosterone in autistic individuals. For example,

  • Geier and Geier (2006) claimed “The use of LUPRON in a large cohort of ASDs of various ages has been observed to be associated with a significant clinical amelioration in hyperactivity/impulsivity, aggression, self injury, severe sexual behaviors, and irritability behaviors that frequently accompany ASDs.”  
  • Realmuto and Ruble (1999) claimed “After failure of behavioral and educational programs, leuprolide, an injectable antiandrogen, resulted in suppression of [sexually inappropriate] behaviors and retention of the participants’ community placement.” 

Key Features

Testosterone is an androgen hormone which regulates the development of the male reproductive system and male secondary sex characteristics (such as facial hair). 

Testosterone regulation involves using drugs called gonadotropin-releasing hormone agonists to reduce the amount of testosterone in the body. 

Brands

There are several different gonadotropin-releasing hormone agonists, each of which is marketed under a variety of brand names. For example, in the UK, leuprolide is marketed as Prostap. In the USA Leuprolide is marketed by Bayer AG under the brand name Viadur, by Sanofi-Aventis under the brand name Eligard, and by TAP Pharmaceuticals under the brand name Lupron.

Administration

There are several different gonadotropin-releasing hormone agonists, each of which may be administered in different ways. For example, according to MedlinePlus (2011), 

“Leuprolide injection comes as a long-acting suspension (Lupron) that is injected intramuscularly (into a muscle) by a doctor or nurse in a medical office or clinic and is usually given once a month (Lupron Depot, Lupron Depot-PED) or every 3, 4, or 6 months (Lupron Depot-3 month, Lupron Depot-PED-3 month, Lupron Depot-4 month, Lupron Depot-6 Month). Leuprolide injection also comes as a long-acting suspension (Eligard) that is injected subcutaneously (just under the skin) by a doctor or nurse in a medical office or clinic and is usually given every 1, 3, 4, or 6 months.”

Dosage

There are several different gonadotropin-releasing hormone agonists, each of which may be available in different doses.

For the latest information on specific formulations please see the British National Formulary (BNF). 

Cost and Time

Cost

The cost of using gonadotropin-releasing hormone agonists will depend on a number of factors including the supplier, the brand, the dosage, and the length and frequency of treatment. 

In the UK gonadotropin-releasing hormone agonists are available free of charge to patients within the NHS who are being treated for recognised medical conditions but not autism. In other countries the costs may be covered by some insurance policies.

For the latest information on costs within the UK please see the British National Formulary.

Please note: We have come across anecdotal reports suggesting that some commercial providers may charge anywhere between $200-$2,000 per leuprolide injection. 

Time

The amount of time required to administer gonadotropin-releasing hormone agonists will depend to a certain extent on how they are administered.  For example, according to MedlinePlus (2011),

“Leuprolide injection comes as a long-acting suspension (Lupron) that is injected intramuscularly (into a muscle) by a doctor or nurse in a medical office or clinic and is usually given once a month (Lupron Depot, Lupron Depot-PED) or every 3, 4, or 6 months (Lupron Depot-3 month, Lupron Depot-PED-3 month, Lupron Depot-4 month, Lupron Depot-6 Month). Leuprolide injection also comes as a long-acting suspension (Eligard) that is injected subcutaneously (just under the skin) by a doctor or nurse in a medical office or clinic and is usually given every 1, 3, 4, or 6 months”.

Risks and Safety

Hazards

Gonadotropin-releasing hormone agonists are very strong drugs, designed to change the hormonal balance in men and women. We believe that, used on children or adolescents, they could cause disastrous and irreversible damage to sexual functioning. 

According to MedlinePlus (2011) leuprolide can cause a wide range of side effects in some people, including tiredness; hot flashes (a sudden wave of mild or intense body heat), sweating, or clamminess; breast tenderness, pain, or change in breast size in both men and women; vaginal discharge, dryness, or itching in women; spotting (light vaginal bleeding) or menstruation (periods) and so on.

More seriously it can also cause redness or swelling at the places where the injection was given; itching, rash, or hives; difficulty breathing or swallowing; pain in the arms, back, chest, neck, or jaw; slow or difficult speech; dizziness or fainting and so on.

For a full list of potential hazards please see US National Library of Medicine. (2011). 

Contraindications

There are some contraindications (something which makes a particular treatment or procedure potentially inadvisable) for gonadotropin-releasing hormone agonists. For example, according to MedlinePlus (2011) leuprolide may be contraindicated for the following groups of people

  • people who are allergic to leuprolide or similar products including other gonadotropin-releasing hormones such as goserelin (Zoladex), histrelin (Supprelin LA, Vantas), nafarelin (Synarel), triptorelin (Trelstar).
  • people who are taking some specified nonprescription medications, nutritional supplements, and herbal products such as amiodarone (Cordarone), disopyramide (Norpace), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine).
  • people who are taking medications for seizures; or oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Sterapred).
  • people who have or have ever had a range of specific diseases and disorders including osteoporosis; depression, diabetes etc.
  • women who are pregnant, who may become pregnant or who are breast-feeding or who have unusual vaginal bleeding.

For a full list of potential contraindications please see US National Library of Medicine. (2011). 

History

Leuprolide was first approved by the FDA for treatment of advanced prostate cancer in 1985. Subsequent variations have been developed by various manufacturers to treat a range of other conditions, including endometriosis and precocious puberty.

It was first suggested as a treatment for inappropriate sexual behaviours in autistic people by Realmuto and Ruble in 1999.

It was then suggested as a treatment for a wide range of other problems in autistic people by M.R. Geir and D.A. Geir in 2005.

Suppliers and Availability

Suppliers 

Gonadotropin-releasing hormone agonists are very powerful drugs with many potential side effects and contradictions. For this reason they should only be obtained on prescription from a GP or other qualified medical professional.

Credentials

Gonadotropin-releasing hormone agonists are very powerful drugs with many potential side effects and contradictions. For this reason they should only be obtained on prescription from a GP or other qualified medical professional.

Current Research

Current Research Studies

We have identified two* studies of testosterone regulation using leuprolide for autistic people published in English-language, peer-reviewed journals.  We have been unable to identify any other studies using other gonadotropin-releasing hormone agonists for the same group.

  • One study (Realmuto and Ruble, 1999) used leuprolide to treat a single male aged 24. It reported that leuprolide resulted in suppression of sexually inappropriate behaviours, such as masturbating in public.
  • One study (Geier and Geier, 2006) combined leuprolide, DMSA (a chelating agent) and a range of other dietary supplements to treat 11 children with autistic disorder aged six to fourteen. It reported that this intervention was associated with significant improvements in hyperactivity/impulsivity, aggression, self-injury, severe sexual behaviors, and irritability behaviors.

*Please note: we have not included another study (Geier and Geier, 2006) which was subsequently retracted by the publisher following extensive criticism.  The publisher’s reasons for retracting the article remain unspecified. However, the Elsevier Policy on Article Withdrawal states that an article can only be retracted under exceptional circumstances, such as "infringements of professional ethical codes, such as multiple submission, bogus claims of authorship, plagiarism, fraudulent use of data or the like."

Status of Current Research Studies

There are a number of limitations to all of the research studies published to date. For example

  • The study by Geier and Geier (2006) was a consecutive case series of eleven children. The study by Realmuto and Ruble (1999) was a retrospective case study of a single adult.
  • The study by Geier and Geier (2006) combined a wide range of different substances (leuprolide, DMSA and dietary supplements), making it difficult to know which substance, if any, caused any of the reported benefits.
  • The study by Geier and Geier (2006) was approved by the ethical board of the organisation of which Geier and Geier are directors, bringing into question the ethics of the study.

Future Research

Summary of Existing Research

There is no high quality research evidence to suggest that regulating testosterone with gonadotropin-releasing hormone agonists is effective in changing the core features of autism.

There is no high quality research evidence to suggest that regulating testosterone with gonadotropin-releasing hormone agonists is effective in reducing challenging behaviours in autistic people.

Recommendations for Future Research

We do not believe that further research into the use of gonadotropin-releasing hormone agonists to reduce testosterone in autistic people is justified, given its potential harmful effects.

Studies and Trials

This section provides details of scientific studies into the effectiveness of gonadotropin-releasing hormone agonistsfor autistic people which have been published in English-language, peer-reviewed journals.

If you know of any other publications we should list on this page please email info@informationautism.org

Please note that we are unable to supply publications unless we are listed as the publisher. However, if you are a UK resident you may be able to obtain them from your local public library, your college library or direct from the publisher.

Related Studies and Trials


Other Reading

This section provides details of other publications on gonadotropin-releasing hormone agonists.

You may be able to find more  publications on gonadotropin-releasing hormone agonists in our publications database.

If you know of any other publications we should list on this page please email info@informationautism.org

Please note that we are unable to supply publications unless we are listed as the publisher. However, if you are a UK resident you may be able to obtain them from your local public library, your college library or direct from the publisher.

Related Other Reading


Personal Accounts

We have identified a number of personal accounts on the use of testosterone regulation in autistic people. These accounts by individuals such as Orac (2006) and Seidel (2006) are extremely hostile to the idea of testosterone regulation for autistic people.

Updated
16 Jun 2022
Last Review
01 Sep 2017
Next Review
01 Jan 2024