How to Stop Testosterone or Anabolics Safely? What PCT Programs Work?

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It Takes a While for Your Body to Start your Own Testosterone and Sperm Production

Some men may want to stop testosterone replacement therapy (TRT) or anabolic androgenic steroids (AAS) due to side effects or the wish to improve fertility. We know that stopping TRT or AAS suddenly can cause declines in quality of life amnd libido as they become hypogonadal due to the shut down of the HPT Axis for a few weeks or month.

In clinical trials of testosterone-based male hormone regimens, serum gonadotropin and testosterone concentrations typically normalize within 1 to 3 months and sperm concentrations typically normalize within 12 to 16 months after cessation of exogenous testosterone. These male hormone contraceptive regimens have used physiologic to modestly supraphysiologic dosages of testosterone for <2 years. A 2017 meta-analysis of the effects of much higher dosages of potent anabolic androgenic steroid (AASs) on the reproductive system of users found only 33 studies (1766 users and 2113 nonuser controls) that met criteria for inclusion; one-half of the subjects were in one cohort study) . Three studies were randomized, controlled trials, and six studies (no randomized, controlled trials) had data on women. There was substantial heterogeneity of the studies and the risk of bias in the studies was unclear. There were seven studies with hormone data (testosterone and/or gonadotropin concentrations) after immediate cessation of AASs and during recovery, and there were three studies (n = 17 AAS users) with hormone data before initiation of AAS use and during recovery from cessation of AAS use. The studies included in this meta-analysis generally had an AAS exposure ≤1 year. Based on limited data, it appears that serum gonadotropins recover to normal concentrations within 3 to 6 months, followed by recovery of serum testosterone to baseline within 6 months in most but not all men who use AASs ≤1 year. Case series have shown that many men who use high-dosage AASs for >1 year will have symptoms suggestive of hypogonadism and serum testosterone concentrations below normal for years after cessation of AAS use.

The Use of Clomiphene (Clomid) to Help Men Who are Stopping Testosterone or AASs

Clomiphene is a selective estrogen receptor modulator that increases serum gonadotropins and testosterone concentrations within 2 to 4 weeks in normal men and in men with intact pituitary function and low or normal serum gonadotropin but low serum testosterone concentrations . One 3-month randomized prospective study and three longer-term cohort studies (mean time of therapy, 1.5 to 2 years) reported no substantial adverse events at dosages of up 100 mg every other day in younger men (<50 years old) with baseline low testosterone concentrations. There were no important adverse events in these studies, but safety data did not appear to be systematically reported. In women, selective estrogen receptor modulators (e.g., clomiphene) increase the risk of venous thrombosis. There are case reports of clomiphene-induced venous thrombosis in men. Anecdotal reports suggest that some male chronic AAS users may have recovery of their hypothalamic-pituitary-gonadal axis after clomiphene therapy for AAS withdrawal.

The benefits of normalization of serum gonadotropins and testosterone followed by potentially improved spermatogenesis 3 to 6 months later might be worth the risk of uncertain safety for some men with AAS use >1 year who are willing to quit using AASs and who are attempting to conceive a child with a female partner as soon as possible. A 6- to 12-month trial of clomiphene at a dosage sufficient to increase serum testosterone to the upper half of the normal range is reasonable in these men. Initiate oral clomiphene 25 mg every other day and increase the dosage by 12.5 to 25 mg every other day (up to 100 mg every other day) based on monthly serum testosterone concentrations. After 3 to 4 months of maintenance of serum testosterone concentrations within the normal range, the dosage of clomiphene is reduced by 12.5 mg every other day at monthly intervals. The clinician should inform the patient that the safety and effectiveness of the approach has not been proven and that clomiphene might increase the risk of venous thrombosis. The clinician must document the conversation in the medical record before prescribing clomiphene.

How About hCG?

Similarly, hCG therapy might be useful in the same group of men. Subcutaneous hCG therapy stimulates testosterone production and spermatogenesis in most men with hypogonadotropic hypogonadism with testes that are ≥6 mL. Administration of hCG suppresses endogenous production of LH and FSH; therefore, the gonadal axis will remain suppressed after discontinuation of hCG. The usual dosage of hCG is 1000 to 2000 IU subcutaneously 2 to 3 times weekly. The dosage is adjusted until serum total testosterone is in the normal range and continued at least until conception. There is more clinical experience and published data on the safety and effectiveness of hCG therapy than clomiphene therapy in men, but there are no data on the comparative effectiveness of these drugs. If a man with a history of long-term AAS use is treated with either hCG or clomiphene fails to have increased serum testosterone concentrations after 3 months of treatment, the clinician should consider the possibility of underlying classic causes of hypogonadism such as Klinefelter syndrome or pituitary tumor.



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In this sample of 59/4,400 men using TRT presenting with infertility, close to 2/3 recovered spermatogenesis within 6 months of T discontinuation.


Samplaski MK, Loai Y, Wong K, Lo KC, Grober ED, Jarvi KA. Testosterone use in the male infertility population: prescribing patterns and effects on semen and hormonal parameters. Fertil Steril. Testosterone use in the male infertility population: prescribing patterns and effects on semen and hormonal parameters

OBJECTIVE: To analyze how frequently and why men presenting with infertility take testosterone (T) and if negative effects of T on semen parameters are reversed following cessation.

DESIGN: Analysis of a prospectively collected database.

SETTING: Male Infertility clinic.

PATIENT(S): Men presenting for fertility evaluation from 2008 to 2012.

INTERVENTION(S): None.

MAIN OUTCOME MEASURE(S): The frequency and reason for T use in the infertile male population, and semen and hormonal parameters while on T and following discontinuation.

RESULT(S): A total of 59/4,400 men (1.3%) reported taking T. T was prescribed by a variety of physicians, including endocrinologists (24%), general practitioners (17%), urologists (15%), gynecologists (5%), and reproductive endocrinologists (3%). Only one of the men admitted that he had obtained T from an illicit source. More than 82% of men were prescribed T for the treatment of hypogonadism, but surprisingly, 12% (7/59) were prescribed T to treat their infertility. While on T, 88.4% of men were azoospermic, but by 6 months after T cessation, 65% of the men without other known causes for azoospermia recovered spermatogenesis.

CONCLUSION(S): In Canada, T was not commonly used by men presenting for fertility investigation (1.3%). Close to 2/3 of infertile men using T recovered spermatogenesis within 6 months of T discontinuation.
 
Great study. Fertility doctors use an array of pharmaceutical tools to induce spermatogenesis. Some include:

Clomiphene Citrate: Clomiphene also works to increase testosterone production. It has been known for many years that clomiphene could be used to test the integrity of the HPA, but several papers have been published in recent years that chronicle the use of this agent as a potentially important means of maintaining sufficient testosterone levels on an on*going basis. Many are familiar with the use of clomiphene in female fertility; it can also be useful in male fertility. At doses ranging from 25 mg every other day to as high as 100 mg daily, clomiphene acts as a selective estrogen receptor modulator (SERM), effectively blocking estradiol from binding to its receptor. With less estrogen binding, GnRH levels increase and lead to increases in LH and FSH secretion. Clomiphene has been compared in at least one head-to-head study with testosterone supplementation and has been shown to be very effective in both restoring hormone levels and reducing signs and symptoms of hypogonadism. Clomiphene overcomes the previously mentioned problem of decreased sperm production seen with testosterone supplementation. For these reasons, clomiphene is one of the best options for men interested in maintaining their fertility.

hCG: Increasing testicular output of testosterone may be the desired option in the case of secondary hypogonadism, a condition in which the testes may be fully intact but are not receiving proper or sufficient signals to produce testosterone. The signal hormones LH may be mimicked by Human Chorionic Gonadotropin (hCG); an injection of hCG can often reactivate the testicular secretion of testosterone, which is required for Sertoli Cells within the testicles to produce sperm, by binding at LH receptors. Dosage requirements vary from patient to patient, with some responding to injections of 500 units three times weekly and others requiring up to 3000 units three times weekly. For some men this may be a very effective way of restoring testosterone to physiologic levels while not suppressing the male's ability to produce sperm. Testosterone supplementation can decrease sperm production by suppressing FSH thru the negative feedback system. It should be noted that treatment to stimulate testicular output of testosterone would not be useful in a man diagnosed with primary testicular failure, in which the testes are unable to produce testosterone (a condition referred to as primary hypogonadism).

FSH: FSH and testosterone act to stimulate and maintain spermatogenesis. FSH acts directly on the Sertoli cells to stimulate germ cell number and acts indirectly to increase androgen production by the Leydig cells. Numerous studies show that FSH increases the numbers of spermatogonia and spermatocytes, and induced round spermatid formation in animals with poor sperm quality and count. For male patients seeking to improve their sperm count, motility and morphology typical dosing of FSH is done at 75 IU subcutaneously every other day.

Here is a nice chart showing how FSH, LH and testosterone work on the male reproductive system:
Male Endocrine Model.jpg
 

Nelson Vergel

Founder, ExcelMale.com
Getting Off Testosterone or Anabolics? You May Want to Read this HPTA protocol

Some men need to stop using testosterone or other androgens because side effects are a problem (e.g. low sperm count interferes with their goal to have children). Most physicians advise the patient to just stop testosterone without thinking about the possible consequences of the hypogonadal state after treatment cessation. Will the patient be worse off than when he started?

Testosterone replacement therapy and anabolic steroids can lead to HPTA (Hypothalamic-Pituitary-Testicular Axis- shown in figure below) dysfunction. Supplemental testosterone can inhibit the release of the body's own testosterone production through negative feedback inhibition on LH levels. This feedback inhibition also results in suppression of FSH levels, leading to suppression of sperm production (spermatogenesis).

Read more here:
How to Stop Testosterone Safely and Possibly Reset Your Hormonal Axis

hpta-axis.jpg
 

KOArtist

New Member
If one was using HCG on M/W/F, and then added HMG, what's the correct dosing protocol? Add in the HMG on Tue/Thurs/Sat? Or do your hcg and hmg on the same days?

Thanks
 

Nelson Vergel

Founder, ExcelMale.com
Here is an excellent powerpoint presentation summarizing the different approaches to attempting to normalize the HPTA after anabolic steroid use in young men.

Managing the Young Hypogonadal Male•Must consider fertility issues in managing hypogonadism in young men.•Most cases of secondary hypogonadism respond to SERM therapy•Tolerance to SERMs relatively uncommon•hCG therapy is an excellent alternative•hCG with testosterone replacement may also work.

Managing the Young Hypogonadal Male
 

Nelson Vergel

Founder, ExcelMale.com
Endocrine Society's 96th Annual Meeting and Expo, June 2. 8211;24, 2014 - Chicago

MON-0017:

Clomiphene Citrate in Anabolic Steroid Users: A Retrospective Review



Mirjana Pavlic1 and Richard Arthur Bebb1University of British Columbia, Vancouver, Canada
Univ of British Columbia, Vancouver, Canada

Presentation Number: MON-0017
Date of Presentation: June 23, 2014


ABSTRACT


Abstract: The anabolic androgenic steroids (AAS) have been used by competitive athletes since1950s, to increase performance, gain muscle and lose body fat. Furthermore, testosterone (T) has been increasingly studied as a potential, reversible male contraceptive agent. Regardless of the reason of exogenous steroid use the consequences are the same and lead to suppression of the hypothalamic-pituitary-gonadal (HPG) axis with all of its negative effects, including decrease in spermatogenesis and testosterone production lasting for several months to years following T exposure. Long-term adverse effects including loss of muscle and increased fat, loss of libido, energy and concentration with impaired quality of life pose a significant problem. More importantly, low testosterone states have been associated with increased mortality. Recommendations for treatment of endogenous testosterone suppression caused by AAS use are not available.

Clomiphene citrate (CC) is a weak estrogen receptor antagonist that competes with estradiol feedback at the pituitary and hypothalamic levels, leading to an increase in LH and FSH, improving steroidogenesis and spermatogenesis in men. There is only a limited amount of evidence to suggest benefit of CC in treatment of AAS induced HPG suppression. Several case reports have been reported, but to date, no larger retrospective studies have been performed.

We preformed a retrospective chart review aiming to assess the effect of CC on HPA axis in AAS users by analyzing T, LH and FSH levels prior and after CC use. Charts at the Men's Health Initiative in Vancouver dating from 1998 to 2013 were searched using keywords including CC, hypogonadism and AAS use. Charts meeting criteria were reviewed and serum T, LH, FSH levels were analyzed at baseline as well as at different time points after initiating therapy to assess for efficacy and duration needed for restoration of HPG axis.

Our hypothesis was that Clomiphene significantly reduces the amount of time needed for HPA recovery in AAS users with specific aims to assess the effect of Clomiphene on HPA axis by analyzing information on testosterone, LH and FSH levels in AAS users prior and after Clomiphene use.

Our results support this as demonstrated by an increase in all three hormones following Clomiphene therapy. There was a 62.9%, 46.7% and 42.2% increase from baseline at 2 months in testosterone, LH and FSH levels respectively, and this was maintained at 57.8%, 46.6% and 43.9% at the 4 month mark (N=6). This reached statistical significance for testosterone levels with p<0.05 at both time points.

This is the first larger retrospective case series to demonstrate clear benefit of clomiphene in restoring HPG axis in AAS users.
 

Nelson Vergel

Founder, ExcelMale.com
Preserving fertility in the hypogonadal patient: an update

Ranjith Ramasamy, Joseph M Armstrong, Larry I Lipshultz

Recovery of spermatogenesis in anabolic steroid suppressed patients

For healthy patients who use exogenous testosterone and are unable to establish a pregnancy because of the deficient spermatogenesis, there are now solutions to reverse the negative impact of testosterone supplementation. In our experience treatment involves discontinuation of exogenous testosterone and administration of 3000 units of hCG (either with the aromatase inhibitor anastrozole or the selective estrogen receptor modulator tamoxifen or clomiphene citrate) intramuscularly every other day for 3 or more months. As higher doses of hCG are known to suppress FSH levels, simultaneous administration of clomiphene citrate not only preserves, but enhances the secretion of FSH and LH from the anterior pituitary. With such treatments, testosterone-induced azoospermia was successfully reversed with hCG therapy in nearly all men receiving treatment. While further studies need to be carried out, every-other-day intramuscular hCG therapy is a viable option in the treatment of men who suffer suppressed spermatogenesis due to testosterone replacement. However, recovery is not immediate; patient spermatogenesis returned in 4-6 months.
 

Nelson Vergel

Founder, ExcelMale.com
Int J Sports Med. 2004 May;25(4):257-63.

Concomitant abuse of anabolic androgenic steroids and human chorionic gonadotrophin impairs spermatogenesis in power athletes.

Karila T1, Hovatta O, Seppälä T.

Abstract

Abuse of anabolic androgenic steroids (AASs) may be an aetiological factor in male infertility among recreational power athletes. They try to avoid AAS-induced deterioration in spermatogenesis by combining doses of human chorionic gonadotrophin (HCG) and/or antiestrogens with their AAS abuse. Eighteen healthy male power athletes using massive doses of AASs were recruited for the study. Semen samples were collected during AAS abuse and 1.5 and 6 months after cessation of the abuse. They were also asked about their reproductive activity six years after the study. At the end of the AAS cycle, the sperm count was 33 +/- 49 x 10 (6) /ml (mean +/- SD), and only one subject had azoospermia. At 1.5 months after cessation of the AAS cycles, the mean sperm concentration was 30 +/- 42 x 10 (6) /ml, and after six months 77 +/- 70 x 10 (6) /ml. There were significant differences between the sample drawn six months after cessation of AAS abuse and both samples drawn during and 1.5 months after the abuse (p </= 0.05, repeated measures of ANOVA). There was a significant positive correlation between HCG dose during the cycle and the relative amount of morphologically abnormal spermatozoa (r = 0.60, p < 0.01). The concomitant abuse of HCG and supraphysiological AAS dose cause transient impairment on semen quality in males, although spermatogenesis is maintained with this regimen despite prolonged abuse of massive doses of AAS.
 
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Nelson Vergel

Founder, ExcelMale.com
In the early eighties endocrinologists in Muenster, Germany gave five young men in their twenties nandrolone hexylphenylproprionate [aka Anadur] for a couple of months and then looked at what happened to the men. Although the doses were very low, the men's bodies needed at least six months to recover from the drugs.

Recovery from mild nandrolone use takes six months

Here is another study that shows that it can take up to 12 months for men's bodies to normalize sperm quality after cessation of testosterone used as a contraceptive.

Sperm normalization after TRT.jpg
 
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Nelson Vergel

Founder, ExcelMale.com
Post Cycle Therapy (PCT) Lecture

This is a great presentation by Dr Paul Turek about post cycle therapy (PCT) in young men.

SERMS PCT.jpg
 

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Nelson Vergel

Founder, ExcelMale.com
Defy Medical HPTA Reset Protocol

by Jasen Bruce

During the previous years large surge in testosterone prescriptions and TRT clinics there are unfortunately many men who have been misdiagnosed with low testosterone, yet placed on TRT when it may not have been needed in the first place. If you are one of these men and you are considering the discontinuation of testosterone treatments there is a protocol that can help restore your own hormone axis. You do not want to stop testosterone "cold turkey", this will lead to unnecessary symptoms that could last for many months.

This is an example of just one protocol, since there really is no "one way" to do it. This has proven a very effective foundational protocol for Defy, but of course every patient is different and therefore treatments are individualized as needed. A good TRT doctor will customize the approach based upon the patients response.

TRT: Endogenous Restoration protocol for Men Discontinuing TRT

Male patients who have been taking any form of exogenous Testosterone long term, longer than 12 weeks, will have secondary hypogonadism induced by the negative feedback response to the exogenous testosterone use. The purpose of this protocol is to stimulate the testes using HCG so that they are able to produce testosterone once again,while also preparing them to respond to endogenous LH/FSH(gonadotropins).


Meds needed:

HCG 11,000iu+mixing kit , 3 refills
Clomiphene 25 mg #30 , 3 refills
Syringes and supplies for HCG

Basic Protocol Begin protocol 5 days after the last T injection (Cyp/Enanth). If the patient is taking a T cream than begin the protocol one day following the last application of T cream.

HCG 300-400 IU daily X 14 days, FOLLOWED by Clomid (clomiphene) 25mg daily X 28 days (6 week cumulative regimen). Request Sildenafil (Viagra) or Tadalafil (Cialis) for any ED. Many patients experience ED during initial recovery.

After regimen is completed, wait 30 days and run this blood work follow up: Testosterone F&T; Sensitive Estradiol; CBC; CMP; LH+FSH

Physician can order additional labs at his/her discretion.

If the total Testosterone is elevated (above 500 ng/dL) at the follow up blood test, then it can be assumed that patient is responding well to the regimen. If not, restart clomiphene for 30 days and retest 30 days after stopping it.


If the patient does not respond to the HCG/clomiphene after 3 cycle, then it can be assumed there is possible primary hypogonadism. This would not have been caused by the TRT, more than likely it has developed naturally with age or has been present for a long time. In this case it is best to suggest continuing TRT so that T levels remain optimal and the patient's life quality and health also remain optimal. Also, some men respond well staying on a low dose of 12.5 mg per day of clomiphene (Clomid).
 
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Nelson Vergel

Founder, ExcelMale.com
Steroids' users hormone balance irreparably damaged after a couple of years - despite post cycling therapy

Average steroids users will have messed up their hormone balance beyond recovery after a few years, endocrinologists at Copenhagen University Hospital discovered. The study raises questions about whether post cycling therapy [PCT] after a course of steroids has any point.
Study


The Danes studied 37 bodybuilders who were taking steroids, 33 bodybuilders who had been clean for 2-3 years, and another 30 bodybuilders who had never taken steroids.

The participants were 18-50 years old and did 6-9 hours of weight training per week.
The active steroids users had been taking anabolics for a total of 142 weeks; the ex-users had taken steroids for 112 weeks. Half of the users and ex-users had taken hCG, a hormone that according to manuals for steroids users helps to restore the hormone balance after a steroid cycle. About a third of the users and ex-users had used anti-estrogens during the post-cycling therapy.
 

Nelson Vergel

Founder, ExcelMale.com
What happens after 14 weeks of weekly injections of 100 mg, 250 mg and 500 mg of testosterone cypionate when patients stop? No PCT. Young and healthy males.

Nice graphs at the end of the paper (attached). Intensive sampling (finally!)


Testosterone returned to baseline at week 23 (last injection at week 14). So, it took 9 weeks for their HPTA to recover, which I find it to be fast for a 500 mg/week dose exposure for 14 weeks. Subjects were healthy and young, so that may have been the reason.


Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Depot Testosterone Cypionate


Study Highlights

WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?
Long-term excessive dosing of anabolic steroids can lead to serious health risks. One of the most significant physiologic changes induced by the use of testosterone esters is a dose-dependent impairment of normal testicular androgen secretion and spermatogenesis.

WHAT QUESTION DID THIS STUDY ADDRESS?
This study characterizes and quantifies changes in testosterone and luteinizing hormone concentration, and spermatogenesis following long-term testosterone cypionate administration.

WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?
The study developed a PK-PD model based on a randomized three-arm (100mg, 250mg, 500 mg/week) clinical trial which quantified the relationship between testosterone exposure after exogenous administration and suppression of LH and spermatogenesis. Model results showed that the suppression of endogenous testosterone secretion, LH synthesis, and spermatogenesis was more severe and of greater duration in 250mg and 500mg dose groups.

HOW MIGHT THIS CHANGE DRUG DISCOVERY, DEVELOPMENT, AND/OR THERAPEUTICS?
This PK/PD model provides a framework to quantify and predict the change in LH and spermatogenesis after exogenous testosterone administration. The average concentration of total testosterone in the past 18 weeks was found to have the strongest association with suppression of spermatogenesis.

Bi Y, Perry PJ, Ellerby M, Murry DJ. Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Depot Testosterone Cypionate in Healthy Male Subjects. CPT: Pharmacometrics & Systems Pharmacology.

A randomized, double-blind clinical trial was conducted to investigate long-term abuse effects of testosterone cypionate. Thirty-one healthy males were randomized into a dose group of 100, 250 or 500mg/wk and received 14 weekly injections of TC.

[The endogenous testosterone secretion rate returned to baseline at approximately week 23 in all three dose groups.]

T levels after stopping testosterone.jpg



Full paper attached for registered members.
 

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Nelson Vergel

Founder, ExcelMale.com
This is Dr Scally's latest PCT protocol:

he updated protocol for HPTA normalization contains:

First 15 days:

HCG 1,000-2,000 IU (subcutaneous) every 3 days;
Clomiphene citrate 25-50 mg orally once a day; and
Tamoxifen 20 mg orally once a day.

A satisfactory testosterone level on day 15, typically 350 ng/mL or greater, is followed by the oral medications (no HCG) for an additional 15 days (25 mg per day clomiphene would be sufficient in most cases).

This protocol has not been tested in many patients but has shown good results in restoring HPTA in a month. I know that this sounds like a long time but without treatment, the body's restoration process would take about the same length of time that somebody was using androgens. In some, HPGA function and testosterone production never returns to normal.
 
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