3-month Depot Research Articles

Sleep and pulmonary intensive care: Insomnia and the paradox of

The International Classification of Sleep Disorders of the American Academy of Sleep Medicine describes insomnia secondary to drugs or substances, highlighting some of the features which characterize it: (a) the iatrogenic nature (b) the diverse range of effects on sleep structure by the different substances, (c) the failure or the partiality of knowledge about it. FG, male, 82 years old, suffering from prostate cancer-treatment with bicalutamide (50 mg/day orally) and leuprorelin (3.75 mg sc per month), is hospitalized in urology for the evidence of two bladder neoplasms. Pre-treated with blood transfusions of G.R. concentrated, is undergoing surgery, in the postoperative setting is further transfused IIa and presents in the day, in the absence of subjectivity and objectivity in character infectious diseases, insomnia and severe decompensated respiratory acidosis associated with acute respiratory failure type II, which progresses despite medical therapy and oxygen-therapy. Speaking to counseling should be the day for the worsening of the clinical picture, is in the differential diagnosis TRALI with bilateral pleural effusions and it starts with the noninvasive mechanical ventilation with interface oro-nasal and oxygen. The urgency in making a HRCT allows you to exclude the commitment interstitial and to confirm the bilateral pleural effusions. Then, are performed in succession, two thoracentesis, right and left, in the course of non-invasive mechanical ventilation, with the respectively extraction of 1000 and 1700 ml of pleural fluid, which turns out to be a transudate. Meanwhile, ventilatory treatment allows a progressive compensation of respiratory failure, the follow-up ultrasound shows the gradual reformation of the pleural effusion bilaterally. The diagnostic analysis is then focused on insomnia marked: you run a PSG in the course of therapy and proves increase of latency, sleep fragmentation and made surface with marked reduction of N2 and especially REM sleep. While the bilateral recurrent hydrothorax is treated with the placement of pleural drainage, a series of investigations in blood chemistry are performed, designed to confirm the suspicion of a clinical condition consistent with the immediacy of insomnia and hydrothorax by drugs and / or substances (surgical stress-Cortisol-CRH-bicalutamide-leuprorelin-FSH-LH-DHEA). Discontinuation of treatment with bicalutamide and dose adjustment of leuprorelin have permission to remove the pleural drainage through exhaustion of recurrence hydro-thorax bilateral. The patient was discharged in XLIIIa day. The knowledge and the cultural-methodological approach of the Sleep Medicine are almost always a real added value for a proper understanding of reality from respiratory clinics proposals in the various forms in which it manifests itself. The clinical case presented is paradigmatic of how Pulmonology intensivist is intimately hawksbill terms of pathophysiology and clinical interpretation, with the Sleep Medicine and how it is useful to have both the same cultural and methodological approaches. 1. Spitz A, Young JM, Larsen L, Mattia-Goldberg C, Donnelly J, Chwalisz K. “Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer”. Prostate Cancer Prostatic Dis. 2011 Oct 25. doi: 10.1038/pcan.2011.50. 2. Tanaka N, Fujimoto K, Hirao Y, Shimizu K, Tsujimoto S, Samma S. “Endocrine response to a single injection of goserelin 3.6 mg or leuprolide 3.75 mg in men with prostate cancer. Arch Androl. 2007 Mar-Apr;53(2):87-90. 3. Ferrari B, Pezzuto A, Coppola F. “Massive ascites and hydrothorax after leuprolide acetate administration in a down-regulated woman undergoing assisted reproduction”. Fertil Steril. 2007 Oct;88(4):968.e9-11. Epub 2007 Apr 16. 4. Lodde M, Lacombe L, Fradet Y. “Salvage therapy with bicalutamide 150 mg in non metastatic castration-resistant prostate cancer”. Urology. 2010 Nov;76(5):1189-93. Epub 2010 Mar 29. 5. Akaza H. “Combined androgen blockade for prostate cancer: review of efficacy, safety and cost-effectiveness”. Cancer Sci. 2011 Jan;102(1):51-6. doi: 10.1111/j.1349-7006.2010.01774.x. Epub 2010 Nov 22. Review. 6. Labrie F. “Hormonal therapy of prostate cancer”. Prog Brain Res. 2010;182:321-41.

Secondary chemoprevention of localized prostate cancer by short-term androgen deprivation to select indolent tumors suitable for active surveillance: a prospective pilot phase II study

To investigate the impact of 3-month androgen deprivation therapy (st-ADT) a secondary chemoprevention of indolent-localized prostate cancer (PCa). A prospective phase II study enrolled men over 4 years with low-risk PCa and the following characteristics: PSA < 10 ng/mL, Gleason score of 6 (3 + 3) or less, three positive cores or less, and tumor stage T2a or less. Patients received a single sub-cutaneous injection of 22.5 mg of leuprolide acetate with Atrigel 3-month depot associated with a daily oral intake of bicalutamide 50 mg/day during 15 days around the injection. Follow-up included PSA and bioavailable testosterone blood tests every 3 months and yearly surveillance biopsies. Primary end point was the presence of PCa on biopsy at last follow-up. Secondary end points were detailed pathological features and adverse events. Overall, 98 men were included and 45 of them (45.9 %) had a negative biopsy after a median follow-up of 13 months [11-19.5]. Of the 53 patients with positive biopsy, 17 had pathologic progression because of upgraded Gleason score (11 patients), four or more positive cores (three patients) or both (three patients). The only significant predictive factor biopsy outcome was the number of positive cores at diagnosis. Secondary chemoprevention by st-ADT for localized PCa could be useful to pinpoint indolent tumors suitable for AS. Indeed, after st-ADT nearly one patient out of two had negative biopsies and 17 % had pathological progression. This is an innovative option to consider as an alternative to current AS protocols contingent upon confirmation in subsequent studies.

Are PSA baseline levels an indicator for suitability of intermittent androgen deprivation in patients with PSA relapse after radical prostatectomy?

136 Background: Intermittent androgen deprivation (IAD) for prostate cancer patients is currently discussed as a treatment option to improve quality of life and to delay hormone resistance. So far only limited data are available indicating whether certain subgroups of patients with PSA relapse without local recurrence after radical prostatectomy are best suited for this therapy. Methods: In a prospective randomized phase III trial, men with unfavourable prognostic factors and a systemic PSA progression (PSA ≥ 1ng/ml) following an initial fall to &lt; 0.5 ng/ml within 3 months after radical prostatectomy were enrolled. They underwent a 6-months androgen deprivation (AD) induction phase with a microencapsulated leuprorelin acetate 3-month depot formulation plus an overlapping antiandrogen to prevent tumor flare-up. Achieving a PSA level &lt; 0.5 ng/ml, they were randomized to either an IAD treatment arm or to continuous AD. In the IAD arm, retreatment was started when PSA rose to ≥ 3 ng/ml. During Off-Treatment-Time (OTT) PSA and Testosterone were controlled on a monthly basis. Results: Analysis of the first IAD cycle, confined as induction phase + OTT, revealed two subgroups of patients with a cycle length ≤ 15 months (group 1) and ≥ 20 months (group 2) respectively. This was due to a significant difference in the time from testosterone normalization (≥ 2.3 ng/ml, TN) to an increased PSA-value ≥ 3 ng/ml. See Table. Conclusions: Our data show a significant (p=0.001) relationship of low PSA baseline levels to delayed biochemical PSA progression during OTT. Thus IAD might be most suitable for patients with low PSA baseline levels leading to a slow increase of PSA after TN during OTT, providing time to improve quality of life and delay potential hormone resistance. Further large scale studies will be necessary to confirm our findings. Clinical trial information: AP 06/95.[Table: see text]

P109 Efficacy and safety of a 3-monthly depot formulation of degarelix compared with goserelin in prostate cancer

P109 Efficacy and safety of a 3-monthly depot formulation of degarelix compared with goserelin in prostate cancer

P110 Efficacy and tolerability of 3- and 6-month depot formulations of leuprorelin acetate for advanced prostate cancer in daily clinical practice: Pooled data from 2 non-interventional studies

P110 Efficacy and tolerability of 3- and 6-month depot formulations of leuprorelin acetate for advanced prostate cancer in daily clinical practice: Pooled data from 2 non-interventional studies

Testosterone recovery in the off-treatment time in prostate cancer patients undergoing intermittent androgen deprivation therapy

Intermittent androgen deprivation (IAD) for prostate cancer was studied with the objective of reducing the side effects of treatment and potentially delaying the development of hormone resistance. There also appears to be a quality of life benefit during off-treatment intervals owing to the recovery of serum testosterone levels. In this multicentre European prospective randomised phase III trial EC507, testosterone serum concentrations were analysed in prostate cancer patients with PSA progression after radical prostatectomy. Patients were randomised to a continuous androgen deprivation (CAD) and IAD therapy using a 3-month depot with 11.25 mg leuprorelin acetate as microcapsule formulation. A complete IAD cycle comprises both a 6-month androgen deprivation therapy plus the off-treatment time (OTT). Serum testosterone recovery was recorded in 109 patients during OTT in the IAD group. Testosterone recovery to baseline values was achieved in 79.3% during the first and in 64.9% during the second IAD cycle, respectively. Median time to testosterone normalisation was 100 days in the first and 115 days in the second cycle, respectively. No significant difference was observed up to 1000 days between IAD and CAD with regard to time to androgen-independent progression. This is the first prospective study of leuprorelin acetate 11.25mg demonstrating normalisation of testosterone levels in the off-treatment period in patients undergoing IAD. The prerequisite of an IAD treatment is the testosterone recovery during off-treatment periods. In this study, in patients with PSA relapse after radical prostatectomy, a real achievement of intermittent castration with normalisation of testosterone levels during off-treatment periods could be confirmed.

Comparison of efficacy and safety of 1- and 3-month luteinizing hormone-releasing hormone agonist depots as initial therapies for prostate cancer

We compared the efficacy and safety of 1- and 3-month depots of the luteinizing hormone-releasing hormone (LH-RH) agonist goserelin acetate in prostate cancer patients. Patients were randomly assigned to the Direct Group that received the goserelin 3-month depot or the Switch Group that began with the 1-month depot for the first 3 months and then switched to the 3-month depot. All patients were co-administered the antiandrogen agent bicalutamide. Serum testosterone and prostate-specific antigen (PSA) levels and adverse events were recorded at weeks 4, 8, 12, and 24. Baseline testosterone levels in the Direct and Switch Groups were 4.98 and 5.07 ng/mL, respectively (P = 0.798). At each week, the levels in both groups were ≤0.50 ng/mL (castration level) with no significant differences between them. All of the patients in the Switch Group and 98.1 % in the Direct Group had achieved castration levels at week 12, and 100 % had achieved such levels at week 24. Baseline PSA levels in the Direct and Switch Groups were 52.37 and 46.72 ng/mL, respectively (P = 0.793). Levels in both groups dropped continuously, to about 1.0 ng/mL at week 24, with no significant differences between the groups at any time. Three patients in the Direct Group experienced adverse events that were attributed to the co-administered bicalutamide. There was no difference in the efficacy or safety between the 1- and 3-month depots of goserelin when given as initial prostate cancer treatment in combination with bicalutamide. Patients must be monitored for adverse events associated with bicalutamide.

Efficacy and Safety of Leuprolide Acetate 3-Month Depot 11.25 Milligrams or 30 Milligrams for the Treatment of Central Precocious Puberty

GnRH agonist (GnRHa) monthly injections are frequently used in the treatment of central precocious puberty (CPP). The 3-month leuprolide depot 11.25- and 30-mg formulations are newly approved treatment options. The aim of the study was to investigate the safety and efficacy of leuprolide acetate 3-month depot formulations for the treatment of CPP in children. This was a phase III, randomized, open-label, dose-ranging 6-month study. Twenty-two U.S. medical centers (including Puerto Rico) participated. Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited. Chronological age at onset of pubertal signs was less than 8 yr in girls and less than 9 yr in boys, and bone age was advanced over chronological age at least 1 yr. Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months. Biochemical [peak-stimulated LH, estradiol (girls), and testosterone (boys)] and anthropometric (growth rate, bone age acceleration, pubertal progression) parameters and safety were assessed. Peak-stimulated LH was suppressed in the 11.25- and 30-mg dose groups in 78.4 and 95.2%, respectively, of children from months 2 through 6. There were nine treatment failures (peak-stimulated LH >4 IU/liter) in the 11.25-mg group and two in the 30-mg group. Basal sex steroid suppression, growth rates, pubertal progression, bone age advancement, and adverse events were similar with either dose. Treatment with leuprolide acetate 3-month depot formulations (11.25 and 30 mg) effectively suppressed the GnRH axis, was well tolerated, and may positively impact patient convenience and compliance.

Phase II Study of Gonadotropin-Releasing Hormone Analog for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients

Premature ovarian failure occurs in 40%-70% of patients who receive conventional chemotherapy alone. However, the incidence is higher, 70%-100%, in patients who undergo myeloablative chemotherapy with hematopoietic stem cell transplantation (HSCT). Gonadotropin-releasing hormone (GnRH) analogs, such as leuprolide, in a continuous-release formulation, may protect the ovaries from the gonadotoxic effects of chemotherapy. In non-HSCT settings, GnRH analogs have reduced the risk for premature ovarian failure to <10%. We conducted a phase II clinical trial based on the hypothesis that giving leuprolide before conditioning chemotherapy in HSCT patients reduces premature ovarian failure incidence. Eligible patients were women aged ≤40 years who were HSCT candidates, were premenopausal, and had both follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels ≤20 IU/L. Two 22.5-mg leuprolide doses were delivered in 3-month depot i.m. injections, the first within 2 months before HSCT. Patients were monitored for menstruation return, and ovarian function tests (FSH, LH, and estradiol) were done every 2 months starting 90 days after the last leuprolide dose. Sixty eligible patients were enrolled, 59 underwent HSCT, and 44 were evaluable (median age, 25 years; median follow-up, 355 days). Only seven of 44 patients (16%) regained ovarian function. Of the 33 who received myeloablative regimens, six (18%) regained ovarian function. However, among the 11 who received nonmyeloablative regimens, only one (9%) regained ovarian function (p = .66). Leuprolide did not preserve ovarian function in patients who underwent HSCT using either myeloablative or nonmyeloablative regimens. Other measures that protect ovarian function need to be investigated.

Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer

Background:This open-label study evaluated the efficacy and safety of a new leuprolide acetate 45 mg 6-month depot formulation in 151 men with prostate cancer who received 2 intramuscular injections administered 24 weeks apart.Methods:The primary efficacy measurement was the proportion of patients achieving suppression of serum testosterone to ⩽50 ng dl−1 from week 4 through week 48. Adverse events (AEs) and hormonal and safety laboratory values were monitored.Results:The primary efficacy end point was achieved in 93.4% of subjects (95% confidence interval (89.2%, 97.6%)). There were nine escapes from testosterone suppression during the study, none of which were accompanied by a rise in PSA. By week 4, mean testosterone concentration was suppressed below castrate levels to 15.9 ng dl−1; suppression was maintained for the entire 24-week duration of each depot injection. No mean increase in testosterone was observed after the second injection. Mean PSA levels were maintained below 3 ng ml−1 from week 14 through the 48-week treatment period. The most frequent AE was flushing (58.3%). Injection site reactions were reported in 24.5% of patients.Conclusions:Leuprolide acetate 45 mg 6-month depot demonstrated rapid and sustained testosterone suppression through 12 months and was well tolerated. This 6-month leuprolide acetate depot will decrease the number of annual injections in the treatment of prostate cancer.

A 6-month depot formulation of leuprolide acetate is safe and effective in daily clinical practice: a non-interventional prospective study in 1273 patients

BackgroundTestosterone stimulates growth in many prostate tumours. The established GnRH analogue leuprolide acetate is incorporated in a novel biodegradable polymer matrix (Atrigel® delivery system), that can be administered to reduce testosterone levels in men with advanced hormone-dependent prostate cancer. This novel formulation is available as a 1-, 3- and most recently 6-month depot (Eligard® 45 mg). The latter was shown to lower and maintain safe and effective serum testosterone suppression in a clinical study.MethodsA non-interventional study to confirm the efficacy and safety of 6-monthly leuprolide acetate (Eligard® 45 mg) in routine urological practice was performed in Germany. Data were obtained from 1273 patients under the care of 634 urologists, and were analysed descriptively. Concentrations of PSA and serum testosterone were documented at the baseline visit and at 6 and 12 months following 6-monthly leuprolide acetate. The participating physicians were also asked to assess the efficacy, tolerabilty and handling of 6-monthly leuprolide acetate.ResultsSerum concentrations of PSA and testosterone were decreased substantially within 6 months of initial 6-monthly leuprolide acetate administration. At 12 months, median reductions of 96% (to 0.5 ng/ml) in PSA, and 90% (to 8.9 ng/dl) in serum testosterone, were observed. Further PSA and serum testosterone decreases were also observed in a subpopulation of patients who switched to 6-monthly leuprolide acetate from other GnRH analogues. Physicians rated 6-monthly leuprolide acetate as easy to use, and patients reported good tolerability. Adverse events occurred in 9% of patients; the majority were not serious. In particular, low rates of hot flushes were reported.ConclusionsThis non-interventional study showed that the reliable reduction of PSA and testosterone levels demonstrated in previous clinical studies of twice-yearly leuprolide acetate can also be achieved in routine clinical practice. This study also confirmed good tolerability of 6-monthly leuprolide acetate in routine clinical use and received positive appraisal from physicians.

A Randomized Trial of 1- and 3-Month Depot Leuprolide Doses in the Treatment of Central Precocious Puberty

To compare 1-month and 3-month depot formulations of leuprolide acetate (DL), a gonadotropin-releasing hormone analog, in the treatment of central precocious puberty (CPP). Subjects with CPP naïve to therapy were randomized to 7.5 mg of 1-month DL, 11.25 mg of 3-month DL, or 22.5 mg of 3-month DL. Stimulated luteinizing hormone (LH) and follicle-stimulating hormone (FSH) and estradiol levels, growth velocity, and bone age progression were examined in a 2-year period. Forty-nine female and 5 male subjects with CPP were randomized. Mean stimulated LH and FSH levels during treatment were higher in the low-dose 11.25-mg 3-month DL group, and more LH levels >4 IU/L were observed, in comparison with the other two dose groups. Mean LH and FSH levels in the 22.5-mg 3-month group were not different from the monthly DL. No differences in estradiol levels, growth velocity, or bone age progression were observed in dosing groups. All DL doses resulted in prompt and effective suppression of puberty, but higher LH and FSH levels were seen with the 11.25-mg 3-month DL dose. Multi-monthly DL is effective in treating CPP, but higher dosing may be required in some circumstances.

Six-month gonadotropin releasing hormone (GnRH) agonist depots provide efficacy, safety, convenience, and comfort.

Two different 6-month GnRH agonist depot formulations approved for palliative treatment of advanced and metastatic prostate cancer in the United States – leuprolide acetate 45 mg and triptorelin pamoate 22.5 mg – provide patients with efficacy and safety comparable to those of existing 1-, 3-, and 4-month GnRH agonist depots. However, the 6-month formulations can increase patient convenience, comfort, and compliance by reducing the number of physician visits and injections required. At the conclusion of their pivotal trials, the 6-month formulations demonstrated efficacy rates in achieving chemical castration (serum testosterone ≤50 ng/dL) that ranged between 93% and 99%. As with existing GnRH agonist depot formulations, hot flashes represented the most common adverse event reported in trials of 6-month leuprolide acetate or triptorelin. As such, these products may prove useful not only for their labeled indication, but also as adjuncts to other treatments such as radical prostatectomy, radiotherapy, and chemotherapy. We recommend further research, including head-to-head trials between the 6-month GnRH depots, to refine our understanding of these products.

Efficacy of Leuprolide Acetate 1-Month Depot for Central Precocious Puberty (CPP): Growth Outcomes During a Prospective, Longitudinal Study.

IntroductionGonadotropin-releasing hormone analogs (GnRHa) are the treatment of choice for CPP. We investigated growth in GnRHa-naïve subjects, treated with leuprolide acetate 1-month depot for CPP.MethodsThis prospective, open-label study had a long-term, observational, follow-up period. Forty-nine females and 6 males were enrolled. Leuprolide acetate depot was administered intramuscularly every 28 days. Height and growth rate during and after treatment until adulthood were measured.ResultsAmong 30 of 49 females having an adult height (AH) measurement, 29 had target heights available (mean = 163.8 cm) and 27 had pretreatment predicted adult heights (PAHs; mean = 157.4 cm). After treatment, the mean AH at mean age 21.8 years [range 13.7-26.7 years] was 162.5 cm, a mean height gain over baseline PAH of 4.0 cm. The mean height standard deviation score was -0.1 at AH.ConclusionsTreatment of CPP with leuprolide acetate 1-month depot had beneficial effects on growth rate and preservation of AH.Trial RegistrationClinicalTrials.gov: NCT00660010

Six-month gonadotropin releasing hormone (GnRH) agonist depots provide efficacy, safety, convenience, and comfort

Six-month gonadotropin releasing hormone (GnRH) agonist depots provide efficacy, safety, convenience, and comfort E David Crawford, Jason M PhillipsUniversity of Colorado Health Sciences Center, Aurora, CO, USAAbstract: Two different 6-month GnRH agonist depot formulations approved for palliative treatment of advanced and metastatic prostate cancer in the United States &ndash; leuprolide acetate 45 mg and triptorelinpalmoate 22.5 mg &ndash; provide patients with efficacy and safety comparable to those of existing 1-, 3-, and 4-month GnRH agonist depots. However, the 6-month formulations can increase patient convenience, comfort, and compliance by reducing the number of physician visits and injections required. At the conclusion of their pivotal trials, the 6-month formulations demonstrated efficacy rates in achieving chemical castration (serum testosterone #50 ng/dL) that ranged between 93% and 99%. As with existing GnRH agonist depot formulations, hot flashes represented the most common adverse event reported in trials of 6-month leuprolide acetate or triptorelin. As such, these products may prove useful not only for their labeled indication, but also as adjuncts to other treatments such as radical prostatectomy, radiotherapy, and chemotherapy. We recommend further research, including head-to-head trials between the 6-month GnRH depots, to refine our understanding of these products.Keywords: prostate cancer, leuprorelin, leuprolide, triptorelin, 6-month depot, testosterone

Effects of depot growth hormone replacement on thyroid function and volume in adults with congenital isolated growth hormone deficiency.

Conflicting data exist on the effects of GH replacement therapy (GHRT) on thyroid function and thyroid volume (TV) in GH-deficient (GHD) patients. The aim of this study was to assess the effects of GHRT on thyroid function and TV in adults with congenital lifetime isolated GHD (IGHD). We studied 20 GH-naïve adults with IGHD due to a homozygous mutation of the GHRH-receptor gene at baseline, after 6-month depot- GH replacement therapy (pGH), and 6-month washout (6mo). Total T(3), free T(4) (FT(4)), reverse T(3) (rT(3)), TSH, IGF-I, SHBG, and TV were measured; body surface area-corrected TV (CTV) was calculated. IGF-I and T(3) increased pGH. T(3) levels remained elevated at 6mo. GHRT did not significantly change FT(4), rT(3), TSH, and SHBG. TV and CTV increased pGH and remained elevated at 6mo. GHRT in IGHD adults caused an increase in serum T(3) levels and TV, suggesting an important role of the GH-IGF-I axis in thyroid function.

Reversal of age-related thymic involution by an LHRH agonist in miniature swine

Background and aims of study We have previously demonstrated a requirement for the presence of a juvenile thymus for the induction of transplantation tolerance to renal allografts by a short-course of calcineurin inhibition in miniature swine. We have also shown that aged, involuted thymi can be rejuvenated when transplanted as vascularized thymic lobes into juvenile swine recipients. The present studies were aimed at elucidating the extrinsic factors facilitating this restoration of function in the aged thymus. In particular, we tested the impact of sex steroid blockade by Luteinizing Hormone-Releasing Hormone (LHRH). Materials and methods 30 naive animals (25 males and 5 females) were used for measurement of serum testosterone levels. 3 mature male pigs (aged at 22, 22 and 29 months old) were used to test the effects of Lupron (LHRH analog) injection at 45 mg (per 70–80 kg body weight) as a 3-month depot on testosterone levels and thymic rejuvenation. Thymic rejuvenation was assessed by histology, flow cytometric analysis, morphometric analysis and TREC assays. Results Hormonal alterations were induced by Lupron and resulted in macroscopic and histologic regeneration of the thymus of aged animals within 2 months, as evidenced by restoration of juvenile thymus architecture and increased cellularity. Two animals that were evaluated for TREC both showed increased levels in the periphery following Lupron treatment. Conclusion Treatment of aged animals with Lupron leads to thymic rejuventaion in adult miniature swine. This result could expand the applicability of thymus-dependent tolerance-inducing regimens to adult recipients.

Efficacy and safety of 6-month depot leuprolide acetate for the treatment of prostate cancer: Results of a 48-week study.

e15042 Background: Leuprolide acetate is a synthetic analog of gonadotropin hormone-releasing hormone (GnRH-a) that reduces serum testosterone to castrate levels after continuous release administra...

Leuprolide acetate 1-month depot for central precocious puberty: hormonal suppression and recovery.

Methods. This prospective US multicenter trial of leuprolide acetate 1-month depot (7.5–15 mg) for central precocious puberty utilized an open-label treatment period, long-term follow-up, and adult callback. Forty-nine females <9 years old with Tanner breast stage ≥2 before 8 years and 6 males <10 years old with Tanner genital stage ≥2 before 9 years with stimulated LH ≥10 IU/L and bone age advance ≥1 year were enrolled. Results. Subjects were treated for 3.9 ± 2.0 years. Mean peak GnRH-stimulated LH and FSH were prepubertal after the first dose and remained suppressed throughout treatment. During treatment, mean estradiol decreased to the limit of detection and mean testosterone decreased but remained above prepubertal norms. During posttreatment follow-up (3.5 ± 2.2 years), all patients achieved a pubertal hormonal response within 1 year and menses were reported in all females ≥12 years old. No impairment of reproductive function was observed at adulthood (mean age: 24.8 years).

Leuprolide Acetate 1-Month Depot for Central Precocious Puberty: Hormonal Suppression and Recovery

Leuprolide Acetate 1-Month Depot for Central Precocious Puberty: Hormonal Suppression and Recovery