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Kenneth A Burry - One of the best experts on this subject based on the ideXlab platform.
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Retreatment with Nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density
Fertility and Sterility, 1997Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Richard M Soderstrom, Veasy C. Buttram, Emil SteinbergerAbstract:Abstract Objective: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal Nafarelin acetate for recurrent symptoms of endometriosis. Design: Multicenter, open-label, nonrandomized clinical trial. Setting: Eleven hospital-based and private practices. Patient(s): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with Nafarelin. Intervention(s): Nasal Nafarelin 200μg twice daily for 3 months. Main Outcome Measure(s): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. Result(s): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. Conclusion(s): Three-month Nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.
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Retreatment with Nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density
Fertility and Sterility, 1997Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Richard M Soderstrom, Veasy C. Buttram, Emil SteinbergerAbstract:Abstract Objective: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal Nafarelin acetate for recurrent symptoms of endometriosis. Design: Multicenter, open-label, nonrandomized clinical trial. Setting: Eleven hospital-based and private practices. Patient(s): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with Nafarelin. Intervention(s): Nasal Nafarelin 200μg twice daily for 3 months. Main Outcome Measure(s): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. Result(s): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. Conclusion(s): Three-month Nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.
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prospective randomized double blind trial of 3 versus 6 months of Nafarelin therapy for endometriosis associated pelvic pain
Fertility and Sterility, 1995Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Veasy C. Buttram, Eric S. OrwollAbstract:Objectives To determine the effectiveness of a 3-month course of Nafarelin and, furthermore, to determine the long-term efficacy in patients treated for 3 and 6 months with Nafarelin for symptoms associated with endometriosis. Design Double-blind, prospective, multicenter, clinical trial. Setting Fifteen reproductive endocrine clinics throughout the United States. Patients One hundred seventy-nine women with pelvic pain and endometriosis. Interventions Patients were assigned randomly to 3 months Nafarelin followed by 3 months of placebo (n=91) or to 6 months Nafarelin (n=88) in a prospective, randomized, double-blind multicenter trial. Patients were followed for 12 months after cessation of therapy. Main Outcome Measures Patient-reported pain scores and physician-reported physical exam findings. Results Pain scores dropped significantly by the end of treatment in both groups. Symptoms recurred in both groups, and pain scores gradually increased during the follow-up period but always remained below baseline in both groups. No significant difference in efficacy was noted between the groups. A total of 26% of patients in each group underwent retreatment for recurrent symptoms. Conclusions A 3-month course of Nafarelin provided effective symptom relief for endometriosis. One year follow-up demonstrated continued pain relief but with gradual return of symptoms.
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Gynecology-endocrinologyProspective randomized double-blind trial of 3 versus 6 months of Nafarelin therapy for endometriosis associated pelvic pain *†
Fertility and sterility, 1995Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Veasy C. Buttram, Le Roy Heinrichs, Eric S. OrwollAbstract:Objectives To determine the effectiveness of a 3-month course of Nafarelin and, furthermore, to determine the long-term efficacy in patients treated for 3 and 6 months with Nafarelin for symptoms associated with endometriosis. Design Double-blind, prospective, multicenter, clinical trial. Setting Fifteen reproductive endocrine clinics throughout the United States. Patients One hundred seventy-nine women with pelvic pain and endometriosis. Interventions Patients were assigned randomly to 3 months Nafarelin followed by 3 months of placebo (n=91) or to 6 months Nafarelin (n=88) in a prospective, randomized, double-blind multicenter trial. Patients were followed for 12 months after cessation of therapy. Main Outcome Measures Patient-reported pain scores and physician-reported physical exam findings. Results Pain scores dropped significantly by the end of treatment in both groups. Symptoms recurred in both groups, and pain scores gradually increased during the follow-up period but always remained below baseline in both groups. No significant difference in efficacy was noted between the groups. A total of 26% of patients in each group underwent retreatment for recurrent symptoms. Conclusions A 3-month course of Nafarelin provided effective symptom relief for endometriosis. One year follow-up demonstrated continued pain relief but with gradual return of symptoms.
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Nafarelin therapy in endometriosis: long-term effects on bone mineral density.
American journal of obstetrics and gynecology, 1994Co-Authors: Eric S. Orwoll, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Veasy C. Buttram, Mark D HornsteinAbstract:Objective: The study intent was to examine long-term effects on bone mass of 3 or 6 months of Nafarelin therapy for endometriosis. Study Design: Women with established endometriosis ( N = 173) were randomized to receive Nafarelin (200 Itg intranasally twice a day) for either 3 or 6 months in a double-blind fashion. Bone mineral density was measured by dual energy x-ray absorptiometry at lumbar spine and proximal femoral sites for 18 months. Results: Bone mineral density declined at spinal and femoral sites similarly in both 3- and 6-month treatment groups. There was a partial, but incomplete, return to baseline levels after 12 to 15 months of follow-up. The recovery of bone mass was more complete in subjects with higher dietary calcium intakes. Conclusion: Nafarelin therapy for endometriosis results in a sustained loss of spinal and femoral bone density, particularly in women with lower calcium intakes.
Mark D Hornstein - One of the best experts on this subject based on the ideXlab platform.
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prevention of estrogen deficiency related bone loss with human parathyroid hormone 1 34 a randomized controlled trial
JAMA, 1998Co-Authors: Joel S Finkelstein, Thomas L Toth, Mark D Hornstein, Anne Klibanski, A Arnold, Robert M. NeerAbstract:Context.—Short-term intermittent administration of parathyroid hormone (PTH) prevents bone loss from the spine in women treated with a gonadotropin-releasing hormone (GnRH) analog. However, the effects of a longer period of PTH administration on bone mass in estrogen-deficient women, particularly on the hip and on cortical bone of the total body, are unknown.Objective.—To determine whether more prolonged PTH administration can prevent estrogen deficiency bone loss from the hip, spine, and total body in young women with endometriosis receiving GnRH analog (Nafarelin acetate) therapy.Design.—Randomized controlled trial.Setting.—General Clinical Research Center of a tertiary care, university-affiliated hospital.Patients.—Forty-three women between the ages of 21 and 45 years with symptomatic endometriosis.Intervention.—Nafarelin alone (200 µg intranasally twice daily) or Nafarelin plus human parathyroid hormone–(1-34) (hPTH-[1-34]) (40 µg subcutaneously daily).Main Outcome Measures.—The primary end points were bone mineral density (BMD) of the anterior-posterior and lateral spine, femoral neck, trochanter, radial shaft, and total body at 12 months of treatment.Results.—In the women who received Nafarelin alone, the mean (SEM) BMDs of the anterior-posterior spine, lateral spine, femoral neck, trochanter, and total body were 4.9% (0.6%) (P<.001), 4.9% (0.8%) (P<.001), 4.7% (1.1%) (P<.001), 4.3% (0.9%) (P<.001), and 2.0% (0.6%) (P=.003) lower than at baseline after 12 months of therapy. In contrast, coadministration of hPTH-(1-34) increased BMD of the anterior-posterior spine by 2.1% (1.1%) (P=.09) and lateral spine by 7.5% (1.9%) (P=.002) and prevented bone loss from the femoral neck, trochanter, and total body, despite severe estrogen deficiency. Radial shaft BMD did not change significantly in either group. Serum bone-specific alkaline phosphatase and osteocalcin concentrations and urinary excretion of hydroxyproline and deoxypyridinoline increased 2-fold to 3-fold during the first 6 to 9 months of therapy in the women who received Nafarelin plus hPTH-(1-34) and then declined. Changes in urinary deoxypyridinolone excretion were strongly predictive (r=0.85) of changes in spinal BMD in the women who received Nafarelin plus hPTH-(1-34).Conclusions.—Parathyroid hormone prevents bone loss from the proximal femur and total body and increases lumbar spinal BMD in young women with GnRH analog–induced estrogen deficiency.
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Prevention of estrogen deficiency-related bone loss with human parathyroid hormone-(1-34) a randomized controlled trial
JAMA, 1998Co-Authors: Joel S Finkelstein, Thomas L Toth, Mark D Hornstein, Anne Klibanski, A Arnold, Robert M. NeerAbstract:Context.—Short-term intermittent administration of parathyroid hormone (PTH) prevents bone loss from the spine in women treated with a gonadotropin-releasing hormone (GnRH) analog. However, the effects of a longer period of PTH administration on bone mass in estrogen-deficient women, particularly on the hip and on cortical bone of the total body, are unknown.Objective.—To determine whether more prolonged PTH administration can prevent estrogen deficiency bone loss from the hip, spine, and total body in young women with endometriosis receiving GnRH analog (Nafarelin acetate) therapy.Design.—Randomized controlled trial.Setting.—General Clinical Research Center of a tertiary care, university-affiliated hospital.Patients.—Forty-three women between the ages of 21 and 45 years with symptomatic endometriosis.Intervention.—Nafarelin alone (200 µg intranasally twice daily) or Nafarelin plus human parathyroid hormone–(1-34) (hPTH-[1-34]) (40 µg subcutaneously daily).Main Outcome Measures.—The primary end points were bone mineral density (BMD) of the anterior-posterior and lateral spine, femoral neck, trochanter, radial shaft, and total body at 12 months of treatment.Results.—In the women who received Nafarelin alone, the mean (SEM) BMDs of the anterior-posterior spine, lateral spine, femoral neck, trochanter, and total body were 4.9% (0.6%) (P
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Retreatment with Nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density
Fertility and Sterility, 1997Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Richard M Soderstrom, Veasy C. Buttram, Emil SteinbergerAbstract:Abstract Objective: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal Nafarelin acetate for recurrent symptoms of endometriosis. Design: Multicenter, open-label, nonrandomized clinical trial. Setting: Eleven hospital-based and private practices. Patient(s): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with Nafarelin. Intervention(s): Nasal Nafarelin 200μg twice daily for 3 months. Main Outcome Measure(s): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. Result(s): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. Conclusion(s): Three-month Nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.
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Retreatment with Nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density
Fertility and Sterility, 1997Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Richard M Soderstrom, Veasy C. Buttram, Emil SteinbergerAbstract:Abstract Objective: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal Nafarelin acetate for recurrent symptoms of endometriosis. Design: Multicenter, open-label, nonrandomized clinical trial. Setting: Eleven hospital-based and private practices. Patient(s): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with Nafarelin. Intervention(s): Nasal Nafarelin 200μg twice daily for 3 months. Main Outcome Measure(s): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. Result(s): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. Conclusion(s): Three-month Nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.
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Use of Nafarelin versus placebo after reductive laparoscopic surgery for endometriosis
Fertility and sterility, 1997Co-Authors: Mark D Hornstein, Albert A Yuzpe, Robert Hemmings, W. Leroy HeinrichsAbstract:Abstract Objective: To evaluate the efficacy of the GnRH agonist (GnRH-a) Nafarelin compared with placebo administered for 6 months after reductive laparoscopic surgery for symptomatic endometriosis. Design: Randomized, prospective, placebo-controlled, multicenter clinical trial. Setting: Thirteen clinics including private practice and university centers. Patient(s): One hundred nine women aged 18–47 with laparoscopically proven endometriosis and pelvic pain who had undergone reductive laparoscopic surgery for endometriosis. Intervention(s): Patients were randomized to receive either the GnRH-a Nafarelin (200 μg twice daily) or placebo for 6 months. Main Outcome Measure(s): Time to initiation of alternative treatment (the length of time from beginning study medication to receiving alternative therapy or to deeming that the study drug was ineffective) and patient-reported and physician-assessed pelvic pain scores. Result(s): The median time to initiation of alternative treatment was > 24 months in the Nafarelin group versus 11.7 months in the placebo group. Fifteen (31%) of 49 Nafarelin-treated patients required alternative therapy, compared with 25 (57%) of 44 placebo-treated patients. The patients' pelvic pain scores dropped significantly in the Nafarelin and placebo groups after 6 months of treatment. Physician summary ratings showed significant improvement in the Nafarelin group and no significant changes in the placebo group after 6 months of treatment. Conclusion(s): Compared with placebo, Nafarelin administered after reductive laparoscopic surgery for endometriosis significantly delays the return of endometriosis symptoms requiring further treatment.
Sergio C Stone - One of the best experts on this subject based on the ideXlab platform.
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comparison between Nafarelin and leuprolide acetate for in vitro fertilization preliminary clinical study
Fertility and Sterility, 1994Co-Authors: Zoetania Nery Dantas, Jose P. Balmaceda, Mario Vicino, Rena Hech Asch, Sergio C StoneAbstract:Objective To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), Nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. Design Twenty-four women were assigned randomly to either Nafarelin acetate or LA during IVF cycles. Setting University-affiliated clinics. Patients Infertile women undergoing IVF cycles in an academic research environment. Interventions Intranasal Nafarelin at a dosage of 200 μ g twice daily or LA at a dose of 1mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. Main Outcome Measure Patient response as indicated by follicular phase serum levels of E 2 , FSH, and LH. Results Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E 2 levels. Patient response as demonstrated by follicular phase of E 2 , FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. Conclusion The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of Nafarelin with prompt nasal absorption and the readily achieved blood level made Nafarelin an option for use in COH in assisted reproductive technology.
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Comparison between Nafarelin and leuprolide acetate for in vitro fertilization: preliminary clinical study * †
Fertility and Sterility, 1994Co-Authors: Zoetania Nery Dantas, Jose P. Balmaceda, Mario Vicino, Rena Hech Asch, Sergio C StoneAbstract:Objective To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), Nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. Design Twenty-four women were assigned randomly to either Nafarelin acetate or LA during IVF cycles. Setting University-affiliated clinics. Patients Infertile women undergoing IVF cycles in an academic research environment. Interventions Intranasal Nafarelin at a dosage of 200 μ g twice daily or LA at a dose of 1mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. Main Outcome Measure Patient response as indicated by follicular phase serum levels of E 2 , FSH, and LH. Results Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E 2 levels. Patient response as demonstrated by follicular phase of E 2 , FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. Conclusion The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of Nafarelin with prompt nasal absorption and the readily achieved blood level made Nafarelin an option for use in COH in assisted reproductive technology.
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Comparison between Nafarelin and leuprolide acetate for in vitro fertilization: preliminary clinical study * †
Fertility and Sterility, 1994Co-Authors: Zoetania Nery Dantas, Jose P. Balmaceda, Mario Vicino, Rena Hech Asch, Sergio C StoneAbstract:Objective To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), Nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. Design Twenty-four women were assigned randomly to either Nafarelin acetate or LA during IVF cycles. Setting University-affiliated clinics. Patients Infertile women undergoing IVF cycles in an academic research environment. Interventions Intranasal Nafarelin at a dosage of 200 μ g twice daily or LA at a dose of 1mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. Main Outcome Measure Patient response as indicated by follicular phase serum levels of E 2 , FSH, and LH. Results Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E 2 levels. Patient response as demonstrated by follicular phase of E 2 , FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. Conclusion The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of Nafarelin with prompt nasal absorption and the readily achieved blood level made Nafarelin an option for use in COH in assisted reproductive technology.
Albert A Yuzpe - One of the best experts on this subject based on the ideXlab platform.
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Retreatment with Nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density
Fertility and Sterility, 1997Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Richard M Soderstrom, Veasy C. Buttram, Emil SteinbergerAbstract:Abstract Objective: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal Nafarelin acetate for recurrent symptoms of endometriosis. Design: Multicenter, open-label, nonrandomized clinical trial. Setting: Eleven hospital-based and private practices. Patient(s): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with Nafarelin. Intervention(s): Nasal Nafarelin 200μg twice daily for 3 months. Main Outcome Measure(s): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. Result(s): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. Conclusion(s): Three-month Nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.
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Retreatment with Nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density
Fertility and Sterility, 1997Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Richard M Soderstrom, Veasy C. Buttram, Emil SteinbergerAbstract:Abstract Objective: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal Nafarelin acetate for recurrent symptoms of endometriosis. Design: Multicenter, open-label, nonrandomized clinical trial. Setting: Eleven hospital-based and private practices. Patient(s): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with Nafarelin. Intervention(s): Nasal Nafarelin 200μg twice daily for 3 months. Main Outcome Measure(s): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. Result(s): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. Conclusion(s): Three-month Nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.
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Use of Nafarelin versus placebo after reductive laparoscopic surgery for endometriosis
Fertility and sterility, 1997Co-Authors: Mark D Hornstein, Albert A Yuzpe, Robert Hemmings, W. Leroy HeinrichsAbstract:Abstract Objective: To evaluate the efficacy of the GnRH agonist (GnRH-a) Nafarelin compared with placebo administered for 6 months after reductive laparoscopic surgery for symptomatic endometriosis. Design: Randomized, prospective, placebo-controlled, multicenter clinical trial. Setting: Thirteen clinics including private practice and university centers. Patient(s): One hundred nine women aged 18–47 with laparoscopically proven endometriosis and pelvic pain who had undergone reductive laparoscopic surgery for endometriosis. Intervention(s): Patients were randomized to receive either the GnRH-a Nafarelin (200 μg twice daily) or placebo for 6 months. Main Outcome Measure(s): Time to initiation of alternative treatment (the length of time from beginning study medication to receiving alternative therapy or to deeming that the study drug was ineffective) and patient-reported and physician-assessed pelvic pain scores. Result(s): The median time to initiation of alternative treatment was > 24 months in the Nafarelin group versus 11.7 months in the placebo group. Fifteen (31%) of 49 Nafarelin-treated patients required alternative therapy, compared with 25 (57%) of 44 placebo-treated patients. The patients' pelvic pain scores dropped significantly in the Nafarelin and placebo groups after 6 months of treatment. Physician summary ratings showed significant improvement in the Nafarelin group and no significant changes in the placebo group after 6 months of treatment. Conclusion(s): Compared with placebo, Nafarelin administered after reductive laparoscopic surgery for endometriosis significantly delays the return of endometriosis symptoms requiring further treatment.
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Therapeutic efficacy and bone mineral density response during and following a three-month re-treatment of endometriosis with Nafarelin (Synarel).
American journal of obstetrics and gynecology, 1997Co-Authors: G. David Adamson, Albert A Yuzpe, Milan R. Henzl, Long Kwei, W. Leroy Heinrichs, Jan J. Jacobson, Christer Bergquist, Staffan Eriksson, Sandra M. GilbertAbstract:Abstract OBJECTIVE: Our goal was to determine the effects of a repeated course of the gonadotropin-releasing hormone agonist Nafarelin on symptoms and signs of endometriosis and lumbar and distal radius bone mineral density. STUDY DESIGN: Forty-five women previously treated for 6 months with Nafarelin, who had recurrent symptoms and signs of endometriosis, received 400 mcg/day of Nafarelin intranasally for 3 months. Efficacy was evaluated by changes in severity of symptoms and signs. Lumbar bone mineral density was measured by dual-energy x-ray absorptiometry and distal radius bone mineral density by single-photon absorptiometry. Bone mineral density was also measured in 10 control volunteers. RESULTS: Repeated 3-month treatment significantly alleviated recurrent symptoms and signs of endometriosis. Lumbar bone mineral density decreased significantly by a mean of 2% at the end of treatment; this loss was restored within 3 to 6 months after treatment completion. No bone mineral density decline occurred in the radius. Bone mineral density changes in the control group were statistically insignificant. CONCLUSIONS: A repeated 3-month course of Nafarelin treatment significantly relieved recurrent endometriotic symptoms and signs without sustained loss of bone mineral density.(Am J Obstet Gynecol 1997;177:8)
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prospective randomized double blind trial of 3 versus 6 months of Nafarelin therapy for endometriosis associated pelvic pain
Fertility and Sterility, 1995Co-Authors: Mark D Hornstein, Kenneth A Burry, Albert A Yuzpe, Leroy Heinrichs, Veasy C. Buttram, Eric S. OrwollAbstract:Objectives To determine the effectiveness of a 3-month course of Nafarelin and, furthermore, to determine the long-term efficacy in patients treated for 3 and 6 months with Nafarelin for symptoms associated with endometriosis. Design Double-blind, prospective, multicenter, clinical trial. Setting Fifteen reproductive endocrine clinics throughout the United States. Patients One hundred seventy-nine women with pelvic pain and endometriosis. Interventions Patients were assigned randomly to 3 months Nafarelin followed by 3 months of placebo (n=91) or to 6 months Nafarelin (n=88) in a prospective, randomized, double-blind multicenter trial. Patients were followed for 12 months after cessation of therapy. Main Outcome Measures Patient-reported pain scores and physician-reported physical exam findings. Results Pain scores dropped significantly by the end of treatment in both groups. Symptoms recurred in both groups, and pain scores gradually increased during the follow-up period but always remained below baseline in both groups. No significant difference in efficacy was noted between the groups. A total of 26% of patients in each group underwent retreatment for recurrent symptoms. Conclusions A 3-month course of Nafarelin provided effective symptom relief for endometriosis. One year follow-up demonstrated continued pain relief but with gradual return of symptoms.
Zoetania Nery Dantas - One of the best experts on this subject based on the ideXlab platform.
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comparison between Nafarelin and leuprolide acetate for in vitro fertilization preliminary clinical study
Fertility and Sterility, 1994Co-Authors: Zoetania Nery Dantas, Jose P. Balmaceda, Mario Vicino, Rena Hech Asch, Sergio C StoneAbstract:Objective To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), Nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. Design Twenty-four women were assigned randomly to either Nafarelin acetate or LA during IVF cycles. Setting University-affiliated clinics. Patients Infertile women undergoing IVF cycles in an academic research environment. Interventions Intranasal Nafarelin at a dosage of 200 μ g twice daily or LA at a dose of 1mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. Main Outcome Measure Patient response as indicated by follicular phase serum levels of E 2 , FSH, and LH. Results Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E 2 levels. Patient response as demonstrated by follicular phase of E 2 , FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. Conclusion The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of Nafarelin with prompt nasal absorption and the readily achieved blood level made Nafarelin an option for use in COH in assisted reproductive technology.
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Comparison between Nafarelin and leuprolide acetate for in vitro fertilization: preliminary clinical study * †
Fertility and Sterility, 1994Co-Authors: Zoetania Nery Dantas, Jose P. Balmaceda, Mario Vicino, Rena Hech Asch, Sergio C StoneAbstract:Objective To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), Nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. Design Twenty-four women were assigned randomly to either Nafarelin acetate or LA during IVF cycles. Setting University-affiliated clinics. Patients Infertile women undergoing IVF cycles in an academic research environment. Interventions Intranasal Nafarelin at a dosage of 200 μ g twice daily or LA at a dose of 1mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. Main Outcome Measure Patient response as indicated by follicular phase serum levels of E 2 , FSH, and LH. Results Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E 2 levels. Patient response as demonstrated by follicular phase of E 2 , FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. Conclusion The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of Nafarelin with prompt nasal absorption and the readily achieved blood level made Nafarelin an option for use in COH in assisted reproductive technology.
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Comparison between Nafarelin and leuprolide acetate for in vitro fertilization: preliminary clinical study * †
Fertility and Sterility, 1994Co-Authors: Zoetania Nery Dantas, Jose P. Balmaceda, Mario Vicino, Rena Hech Asch, Sergio C StoneAbstract:Objective To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), Nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. Design Twenty-four women were assigned randomly to either Nafarelin acetate or LA during IVF cycles. Setting University-affiliated clinics. Patients Infertile women undergoing IVF cycles in an academic research environment. Interventions Intranasal Nafarelin at a dosage of 200 μ g twice daily or LA at a dose of 1mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. Main Outcome Measure Patient response as indicated by follicular phase serum levels of E 2 , FSH, and LH. Results Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E 2 levels. Patient response as demonstrated by follicular phase of E 2 , FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. Conclusion The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of Nafarelin with prompt nasal absorption and the readily achieved blood level made Nafarelin an option for use in COH in assisted reproductive technology.