A new 2% testosterone gel formulation: a comparison with currently available topical preparations

Arver, Stefan; Stief, Christian G.; Rosette, Jean de la; Jones, T. Hugh; Neijber, Anders; Carrara, D.

doi:10.1111/andr.12487

Cited by 18 publications

(16 citation statements)

References 52 publications

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“…These results are in line with the literature10,11 suggesting that process features such as ease of use and convenience play an important role in patient preference for TRT in addition to the alleviation of symptoms associated with low testosterone levels. Knowledge of individual patient preferences for TRT within the clinical consultation process should lead to better patient adherence to medication leading to an improved clinical response and ultimately to greater symptom control and patient health-related quality of life 10…”

Section: Discussionsupporting

confidence: 91%

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<p>Preferences for the administration of testosterone gel: evidence from a discrete choice experiment</p>

Retzler¹,

Smith²,

Gonçalves³

et al. 2019

PPA

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Objectives: Differences in testosterone replacement therapy (TRT) gel products may affect patient satisfaction, quality-of-life, and treatment response and adherence. This study investigated preferences for TRT gel in terms of formulation and administration. Methods: 525 male adults aged 45 years and over completed a discrete choice experiment. Respondents made repeated choices between two hypothetical testosterone gel treatments described according to four attributes: form, ease of use, impact of use on showering/swimming, and location/dosage of the application. Choice data were analyzed using a latent class model. Results: Three preference classes were identified. Respondents across all classes displayed a preference for the gel being dispensed in smaller units with accurate dosing, waiting shorter times after the gel application before swimming/showering, and using 2.5 gm of gel to be applied to the inner thigh/abdomen as opposed 5 gm to shoulder/abdomen. The importance of these characteristics differed across classes, with preference class membership predicted by age and education level. For instance, younger men (aged 45–64 years) were more likely to belong to a class that prioritized reduced waiting time before being able to undertake activities. Formulation was not an important driver of choice. Conclusions: Preferences demonstrate a predilection for TRT gel dispensed in small units allowing precise dosing, shorter waiting time after application, and application to the inner thigh/abdomen. However, the strength of importance of these characteristics differs between men. This study highlights the attributes of TRT gel considered important to patient subgroups, and which may ultimately affect treatment response, medication adherence, and patient quality-of-life.

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Section: Discussionsupporting

confidence: 91%

“…In addition to efficacy, manufacturers of TRT gels are becoming increasingly aware of the need to develop products that aim to minimize inconvenience to the patient, thereby improving the patient experience and increasing patient satisfaction while maintaining the level of effectiveness 9–11…”

Section: Introductionmentioning

confidence: 99%

<p>Preferences for the administration of testosterone gel: evidence from a discrete choice experiment</p>

Retzler¹,

Smith²,

Gonçalves³

et al. 2019

PPA

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“…Commercially available T gels have the same amount of T, but differences in absorption (due to differences in excipients and absorption enhancers) result in significant variation in the percentage of testosterone delivered per dosage (Arver et al . ). We used a commercial, proprietary T gel (Androgel III 1.62%) and a combination Nes‐T gel manufactured by Particle Science using the same formulation and excipients as the proprietary T gel under the supervision of the Population Council scientists.…”

Section: Discussionmentioning

confidence: 97%

Combined nestorone–testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men

et al. 2019

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Background: Novel male-based contraceptives are needed to broaden family planning choices. A progestin, Nestorone â (Nes) gel, plus a testosterone (T) gel suppresses sperm concentrations to levels associated with effective contraception in normal men. However, administration of two gels on different parts of the body daily is impractical. Objective: Compare the effectiveness of daily application of a single, combined 8.3 mg Nes-62.5 mg T gel (Nes-T) vs. 62.7 mg T gel to suppress serum FSH and LH concentrations to ≤1.0 IU/L (a threshold associated with suppression of sperm concentrations to ≤1 million and effective contraception) and to compare the pharmacokinetics of serum Nes and T concentrations between the gel groups. Design: We conducted a 28-day, double-blind, controlled trial of 44 healthy men randomized to daily Nes-T or T gel with measurement of hormones at baseline, treatment, and recovery and during 24-h pharmacokinetic studies on days 1 and 28 of treatment. Results: Of the subjects who met pre-defined inclusion criteria, 84% of the Nes-T group suppressed serum gonadotropin concentrations to ≤1.0 IU/L at days 21-28 vs. 16.7% in the T group (p < 0.001). On day 1, Nes concentrations rose significantly above baseline by 2 h and continued to rise up to 24 h after Nes-T gel application. Nes concentrations were not detectable in the T group. Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01). There were no serious adverse events in either group. About 80% of the subjects reported satisfaction with both gels. Conclusion: Daily Nes-T gel effectively and safely suppresses serum gonadotropins and is acceptable to most men. It should be studied further in efficacy trials of hormonal male contraception.

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“…A 2% T gel comes in a metered‐dose dispenser that includes a hands‐free cap applicator for precise dispensing and application. This avoids exposure to the hands, which minimizes the risk of transfer 41. USA Boxed Warning was hence eliminated for this product.…”

Section: Introductionmentioning

confidence: 99%

“…The dose can be adjusted based on serum levels measured two hours after morning application 14 days after initiation or adjustments,46 or 4 hours post‐dosing on days 14, 35 and 56 from initiation 41. Dosing range is 10‐70 mg/d46 or 23‐69 mg/d 41. The effect of 2% gel on serum T levels was evaluated in a multicentre, open‐label study of 129 men with hypogonadism 46.…”

Section: Introductionmentioning

confidence: 99%

Testosterone replacement therapy

2020

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Background The aim of testosterone replacement therapy (TRT) is to improve symptoms and signs of testosterone deficiency including decreased libido, erectile dysfunction, depressed mood, anaemia, loss of muscle and bone mass, by increasing serum testosterone levels to physiologic range. TRT has been used in the last 70 years, and overtime, numerous preparations and formulations have been developed to improve pharmacokinetics (PKs) and patient compliance. The routes of delivery approved for use in the Western world include buccal, nasal, subdermal, transdermal and intramuscular (IM). Objectives The aim of this narrative review was to describe and compare all available and approved testosterone preparations according to pharmacology, PKs and adverse effects. Materials and Methods We have performed an extensive PubMed review of the literature on TRT in clinical practice. Contraindications and monitoring of TRT were analyzed by comparing available guidelines released in the last five years. We provide a review of advantages and disadvantages of different modalities of TRT and how to monitor treatment to minimize the risks. Results TRT is associated with multiple benefits highly relevant to the patient. However, the recommendations given in different guidelines on TRT are based on data from a limited number of randomized controlled trials (RCTs), as well as non‐randomized clinical studies and observational studies. This is the case for the safety of a long‐term TRT in late‐onset hypogonadism (LOH). No evidence is provided indeed on the effects of TRT on endpoints such as deterioration of heart failure suggesting a cautious approach to T replacement in older men with a history of heart failure. Conclusion Clinicians must consider the unique characteristics of each patient and make the necessary adjustments in the management of LOH in order to provide the safest and most beneficial results.

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A new 2% testosterone gel formulation: a comparison with currently available topical preparations

Cited by 18 publications

References 52 publications

<p>Preferences for the administration of testosterone gel: evidence from a discrete choice experiment</p>

<p>Preferences for the administration of testosterone gel: evidence from a discrete choice experiment</p>

Combined nestorone–testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men

Testosterone replacement therapy

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