PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE IN TESTOSTERONE-DEFICIENT MEN WITH PREVIOUS TESTOSTERONE THERAPY

[Nelson Vergel]

MP79-01 PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE IN TESTOSTERONE-DEFICIENT MEN WITH PREVIOUS TESTOSTERONE THERAPY: AN OPEN-LABEL, SINGLE-CENTER, PHASE IV CLINICAL TRIAL

Marco-Jose Rivero, R. Reddy, +1 author R. Ramasamy
Published 1 April 2023
Medicine, Biology
The Journal of Urology

INTRODUCTION AND OBJECTIVE: Testosterone therapy (TTh) is available in multiple modalities. Oral formulations, previously unavailable in the United States due to variable bioavailability, are convenient, easy to use, and free of painful injections. Testosterone undecanoate (TU) is a recently approved oral testosterone capsule that provides a uniform response in patients with testosterone deficiency. In this study, we evaluated patient satisfaction with TU in men with a recent history of alternative TTh.

METHODS: Patients between 18 and 65 years of age with a diagnosis of testosterone deficiency were recruited. Testosterone deficiency (TD) was defined as two measurements of serum total testosterone below 300 ng/dL combined with one or more characteristic clinical symptoms. Patients were required to have received previous TTh and completed an adequate washout period prior to starting TU. The primary outcomes were patient satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9); and TD symptom control, measured by the quantitative Androgen Deficiency in Aging Males (qADAM) questionnaire at 3and 6-month intervals. Routine blood tests were also performed at each time point.

RESULTS: Of the 43 patients recruited into the study, 47% had previously received subdermal pellets, 40% intramuscular injections, and 12% intranasal gels. After the appropriate washout period, serum total testosterone levels increased from a baseline mean of 193.4 ng/dL to 747.9 ng/dL at 1 month, 500.6 ng/dL at 3 months, and 692.2 ng/dL at 6 months of treatment with TU. Mean global satisfaction measured by TSQM-9 progressed from 64.1 with previous TTh to 80.2 at 3 months (p[0.011) and 88.8 at 6 months (p<0.001) of treatment with TU. Similar 6-month changes were observed for TSQM-9 measures of effectiveness (p<0.001) and convenience (p<0.001). Mean TD symptom control measured by qADAM at 6 months (35.0) was statistically unchanged from baseline (36.8, p[0.154). No significant changes were noted in hematocrit, prostate-specific antigen, or estradiol throughout the study period.

CONCLUSIONS: TU provides patient satisfaction and TD symptom control that is noninferior compared to other forms of TTh. In addition, TU increases serum total testosterone to reference range (300-1000 ng/dL) in >90% of men without a difference in side effect profile over 6 months of treatment.

 

[Biobro]

MP79-01 PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE IN TESTOSTERONE-DEFICIENT MEN WITH PREVIOUS TESTOSTERONE THERAPY: AN OPEN-LABEL, SINGLE-CENTER, PHASE IV CLINICAL TRIAL

Marco-Jose Rivero, R. Reddy, +1 author R. Ramasamy
Published 1 April 2023
Medicine, Biology
The Journal of Urology

INTRODUCTION AND OBJECTIVE: Testosterone therapy (TTh) is available in multiple modalities. Oral formulations, previously unavailable in the United States due to variable bioavailability, are convenient, easy to use, and free of painful injections. Testosterone undecanoate (TU) is a recently approved oral testosterone capsule that provides a uniform response in patients with testosterone deficiency. In this study, we evaluated patient satisfaction with TU in men with a recent history of alternative TTh.

METHODS: Patients between 18 and 65 years of age with a diagnosis of testosterone deficiency were recruited. Testosterone deficiency (TD) was defined as two measurements of serum total testosterone below 300 ng/dL combined with one or more characteristic clinical symptoms. Patients were required to have received previous TTh and completed an adequate washout period prior to starting TU. The primary outcomes were patient satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9); and TD symptom control, measured by the quantitative Androgen Deficiency in Aging Males (qADAM) questionnaire at 3and 6-month intervals. Routine blood tests were also performed at each time point.

RESULTS: Of the 43 patients recruited into the study, 47% had previously received subdermal pellets, 40% intramuscular injections, and 12% intranasal gels. After the appropriate washout period, serum total testosterone levels increased from a baseline mean of 193.4 ng/dL to 747.9 ng/dL at 1 month, 500.6 ng/dL at 3 months, and 692.2 ng/dL at 6 months of treatment with TU. Mean global satisfaction measured by TSQM-9 progressed from 64.1 with previous TTh to 80.2 at 3 months (p[0.011) and 88.8 at 6 months (p<0.001) of treatment with TU. Similar 6-month changes were observed for TSQM-9 measures of effectiveness (p<0.001) and convenience (p<0.001). Mean TD symptom control measured by qADAM at 6 months (35.0) was statistically unchanged from baseline (36.8, p[0.154). No significant changes were noted in hematocrit, prostate-specific antigen, or estradiol throughout the study period.

CONCLUSIONS: TU provides patient satisfaction and TD symptom control that is noninferior compared to other forms of TTh. In addition, TU increases serum total testosterone to reference range (300-1000 ng/dL) in >90% of men without a difference in side effect profile over 6 months of treatment.

Good for US guys.
Its shame we dont have any good oral T here in europe. Waiting till jatenzo arrives here (if arrives) in some lucky day.

 

[Fortunate]

I have tried Jatenzo a few times. My input may be somewhat meaningless, but I thought I'd provide it.

I have had a few trials that have lasted about a week or so. It seemed like early in the week, I'd really feel hypogonadal for several hours in the morning until the AM dose started to push t levels up. I'd feel decent, and sometimes really good, for a few hours. I'd then start to feel hypogonadal for another few hours until it was time to take the second dose. As the week wore on, it seemed like the peaks and valleys were less severe. It felt like the experience was becoming more uniform. I stopped because I was having severe abdominal bloating and discomfort. I wasn't sure what it was from, but Jatenzo seemed to be the most likely culprit, so I stopped.

I then trialed it again, but after a few days, it again felt like I was experiencing GI bloating. I have no idea if it was the Jatenzo in either case, but the first GI episode was very unpleasant, so I just decided to stop the second trial.

The other challenge I ran into was timing. I get up pretty early, but usually don't eat much in the morning. When I do eat, it's typically an hour or so after I get up. But, to avoid feeling hypogonadal through much of the morning, I had to force myself to eat right when I got up. Also, I wanted the treatment to be most noticeable and/or efficacious while I was awake, so taking the second dose at 6-8 at night didn't seem to make great sense to me, as I am usually in bed by 9-10PM.

To make the timing work, I forced myself to eat early (around 6AM), and to make sure I was not bottomed out during a prime part of my day 4-7PM, I would take the second dose a bit early, at about 4:30 PM.

The GI stuff is really why I stopped the most recent trial, but the meal requirement and timing was also a challenge for me. I was on the usual starting dose of 237mg BID, and overall, I felt hypogonadal much of the time. I suspect this gets better once your reach steady state. That said, I think of steady state as the state in which the Cavg levels are not changing over a specified period of time - when the absorption and elimination rates are not changing any more (@readalot, feel free to correct my simplistic thought on this). Even at steady state, you are still cratering your T levels in the middle of your day.

As a long time Natesto user, you'd think a once-a-day bottom out would be better than several times a day, but it just didn't feel great. Maybe because Natesto is so fast acting compared to Jatenzo, which takes hours to push levels up. Again, one week is nothing, but I really wanted to make this work. I am envious of @Systemlord. Has anyone else around here had any better luck than me? I haven't ruled out orals in the future, but I'll probably wait until there is an extended release option with once a day dosing.

 

[madman]

Patient Satisfaction After Switching to Jatenzo (Oral TU)

Patient Satisfaction After Switching to Jatenzo (Oral Testosterone Undecanoate): Update on an Open-label, Single-arm Clinical Trial (2022) Rohit Reddy, Marco-Jose Rivero, Mehul Patel, Akhil Muthigi, Ranjith Ramasamy, Parris Diaz 1. Introduction Testosterone deficiency (TD) is defined as...

www.excelmale.com

 

[sammmy]

@Fortunate

Jatenzo contains hydrogenated castor oil, which is a laxative. Maybe that's why they added also peppermint oil in it, since it has the reputation to relieve stomach cramps and bloating but clearly not succeeding in your case.

 

[Fortunate]

@Fortunate

Jatenzo contains hydrogenated castor oil, which is a laxative. Maybe that's why they added also peppermint oil in it, since it has the reputation to relieve stomach cramps and bloating but clearly not succeeding in your case.

In fairness, I can’t say definitively if it was the Jatenzo, but I did strongly suspect it.

 

[Fortunate]

I also happen to be on Accutane at the moment. I suspect on Accutane probably has some negative G.I. impact. I would like to give Jatenzo another try once I’m off Accutane in about three weeks. If so, I will report back.

 

[Fortunate]

This is odd: the same article title was published in a different journal with different results. The article was published a month after the one referenced in the original post here and the results are worse. The 3 and 6 month total T levels are a lot lower than what is referenced in the original article.

Total testosterone levels increased from a baseline after appropriate washout from a mean of 187 ng/dL to 773 ng/dL at 1 month, 434 ng/dL at 3 months, and 397 at 6 months of treatment with Jatenzo.

The original article had 41 patients, and this study had 43. Same age range. I can't imagine these are different groups of patients. Even if they were, two patients would not affect the total T levels at 3 and 6 months so profoundly.

Why do the 3 and 6 month results show such a big drop from month 1? I am not sure most guys would feel great with 397 ng/dL at 6 months. What am I missing here?

 

[madman]

This is odd: the same article title was published in a different journal with different results. The article was published a month after the one referenced in the original post here and the results are worse. The 3 and 6 month total T levels are a lot lower than what is referenced in the original article.

The original article had 41 patients, and this study had 43. Same age range. I can't imagine these are different groups of patients. Even if they were, two patients would not affect the total T levels at 3 and 6 months so profoundly.

Why do the 3 and 6 month results show such a big drop from month 1? I am not sure most guys would feel great with 397 ng/dL at 6 months. What am I missing here?

Did you even look over the original paper 8/12/22 from my thread 9/6/22 that I linked up in post #4.

Notice the number of patients from week 1--->4--->14--->27.

There was a dose titration at week 4 (follow-up visit) in 24% of the patients (N=35).

*24% of patients required uptitration, while none required downtitration

Key points:

*While the study features of close bloodwork follow-up and mandatory titration allowed for medical optimization, twice-daily doses were far more frequent for the oral form in comparison to intramuscular and pellet therapies and posed a higher risk of missed doses and poorer compliance

* The reason most often cited for dropout was an unsatisfactory symptom response

*Closer examination of the results revealed that individuals who were previously receiving testosterone pellets or nasal testosterone were more satisfied than patients in the intramuscular testosterone cypionate arm




3. Results

Of the 41 patients enrolled in the study, 46% were previously on subdermal pellets, 41% on intramuscular injections, and 13% on nasal gels. Testosterone levels increased from a baseline median of 192.0 ng/dl to 738.5 ng/dl (618.3–896.8) at 1 mo, 481.5 ng/dl (349.3–646.3) at 14 wk, and 575.0 ng/dl (336.0–680.5) at 6 mo. Some 24% of patients required uptitration, while none required downtitration. Patient satisfaction on oral TU in terms of TSQM-9 scores increased from 42.0 (34.0–51.0) on the prior TTh to 49.0 (39.0–57.0) at 14 wk (p = 0.02) and 55.0 (52.0–59.0) at 6 mo (p = 0.0013).

Closer examination of the results revealed that individuals who were previously receiving testosterone pellets or nasal testosterone were more satisfied than patients in the intramuscular testosterone cypionate arm. Hypogonadal symptoms in terms of qADAM scores were regarded as similar at 34.4 at 14 wk (p = 0.16) and 35 at 6 mo (p = 0.83) in comparison to 32.5 on prior testosterone therapy. The reason most often cited for dropout was an unsatisfactory symptom response. We evaluated changes in HCT, prostate-specific antigen, and serum estradiol after testosterone therapy and found that the levels were similar before and after TTh. Of note, phlebotomy was recommended for 16% of the men during the trial.


4. Discussion

This is the first study investigating patient satisfaction among men receiving oral TU who were previously using other forms of TTh. Over the course of the trial, oral TU appeared to lead to greater patient satisfaction in comparison to previous TTh modalities and a similar improvement in hypogonadal symptoms. In addition, oral TU increased serum total testosterone to the normal range (300–1000 ng/dl) in >90% of the men without a difference in side effect profile. While the study features of close bloodwork follow-up and mandatory titration allowed for medical optimization, twice-daily doses were far more frequent for the oral form in comparison to intramuscular and pellet therapies and posed a higher risk of missed doses and poorer compliance. Beyond the results from this trial, future studies should investigate patient satisfaction and side effect profiles in a larger population to support practical adoption by patients and practitioners

 

[madman]

FDA Approves Oral Testosterone Replacement Therapy Kyzatrex

Another oral testosterone undecanoate. https://www.empr.com/home/news/fda-approves-oral-testosterone-replacement-therapy-kyzatrex/

www.excelmale.com

A pill that could outsell Viagra: New testosterone Rx drug

https://www.americanbazaaronline.com/2022/10/11/testosterone-drug-kyzatrex-hits-market-451261/ Kyzatrex could be a potential blockbuster to treat testosterone deficiency, a severely undertreated disease. Testosterone has been historically perceived as a lifestyle issue for men who want to...

www.excelmale.com

 

[Systemlord]

Patient Satisfaction After Switching to Jatenzo (Oral TU)

Patient Satisfaction After Switching to Jatenzo (Oral Testosterone Undecanoate): Update on an Open-label, Single-arm Clinical Trial (2022) Rohit Reddy, Marco-Jose Rivero, Mehul Patel, Akhil Muthigi, Ranjith Ramasamy, Parris Diaz 1. Introduction Testosterone deficiency (TD) is defined as...

www.excelmale.com

I’m very satisfied with Jatenzo! My Total T is so damn consistent! It’s always where I expect to see it when testing, whether that’s at 2, 3, 4 , 5 and 6 hours after dosing.

My Experience On Jatenzo (Oral TRT) Log

 

[Fortunate]

Did you even look over the original paper 8/12/22 from my thread 9/6/22 that I linked up in post #4.

Notice the number of patients from week 1--->4--->14--->27.

There was a dose titration at week 4 (follow-up visit) in 24% of the patients (N=35).

*24% of patients required uptitration, while none required downtitration

View attachment 35393




Key points:

*While the study features of close bloodwork follow-up and mandatory titration allowed for medical optimization, twice-daily doses were far more frequent for the oral form in comparison to intramuscular and pellet therapies and posed a higher risk of missed doses and poorer compliance

* The reason most often cited for dropout was an unsatisfactory symptom response

*Closer examination of the results revealed that individuals who were previously receiving testosterone pellets or nasal testosterone were more satisfied than patients in the intramuscular testosterone cypionate arm




3. Results

Of the 41 patients enrolled in the study, 46% were previously on subdermal pellets, 41% on intramuscular injections, and 13% on nasal gels. Testosterone levels increased from a baseline median of 192.0 ng/dl to 738.5 ng/dl (618.3–896.8) at 1 mo, 481.5 ng/dl (349.3–646.3) at 14 wk, and 575.0 ng/dl (336.0–680.5) at 6 mo. Some 24% of patients required uptitration, while none required downtitration. Patient satisfaction on oral TU in terms of TSQM-9 scores increased from 42.0 (34.0–51.0) on the prior TTh to 49.0 (39.0–57.0) at 14 wk (p = 0.02) and 55.0 (52.0–59.0) at 6 mo (p = 0.0013).

Closer examination of the results revealed that individuals who were previously receiving testosterone pellets or nasal testosterone were more satisfied than patients in the intramuscular testosterone cypionate arm. Hypogonadal symptoms in terms of qADAM scores were regarded as similar at 34.4 at 14 wk (p = 0.16) and 35 at 6 mo (p = 0.83) in comparison to 32.5 on prior testosterone therapy. The reason most often cited for dropout was an unsatisfactory symptom response. We evaluated changes in HCT, prostate-specific antigen, and serum estradiol after testosterone therapy and found that the levels were similar before and after TTh. Of note, phlebotomy was recommended for 16% of the men during the trial.


4. Discussion

This is the first study investigating patient satisfaction among men receiving oral TU who were previously using other forms of TTh. Over the course of the trial, oral TU appeared to lead to greater patient satisfaction in comparison to previous TTh modalities and a similar improvement in hypogonadal symptoms. In addition, oral TU increased serum total testosterone to the normal range (300–1000 ng/dl) in >90% of the men without a difference in side effect profile. While the study features of close bloodwork follow-up and mandatory titration allowed for medical optimization, twice-daily doses were far more frequent for the oral form in comparison to intramuscular and pellet therapies and posed a higher risk of missed doses and poorer compliance. Beyond the results from this trial, future studies should investigate patient satisfaction and side effect profiles in a larger population to support practical adoption by patients and practitioners

I’ll need to look closer