nafarelin and Body-Weight

To compare the efficacy and safety of nafarelin and danazol for endometriosis.. Randomized, double-blind, double-dummy.. Multiple European institutions.. In total, 307 patients with laparoscopically diagnosed endometriosis received nafarelin (n = 206) or danazol (n = 101); 263 (171 nafarelin, 92 danazol) were analyzed for efficacy.. Intranasal nafarelin 200 micrograms two times a day or oral danazol 200 mg three times a day were administered for 6 months.. Efficacy assessments were based on preadmission and end-of-treatment laparoscopic scores and subjective symptom scores at admission, end of treatment, 1, 3, 6, and 12 months after treatment. Safety was evaluated by adverse events and clinical laboratory tests.. In each group, endometriosis growth and symptoms significantly improved during treatment (P less than 0.001). After treatment, symptoms returned in each group, but severity was less than at admission at all time points (P less than or equal to 0.016). Mean body weight increased in the danazol-treated group (P less than 0.001), serum glutamic oxaloacetic transaminase increased in both groups (P less than 0.001 for both) but significantly more in danazol users (P less than 0.002), and more nafarelin recipients had hot flushes (P less than 0.001).. Nafarelin and danazol were equally effective in reducing endometriosis growth and symptoms during treatment and in preventing the return of symptoms during 12-month follow-up.

Topics: Administration, Intranasal; Administration, Oral; Adult; Aspartate Aminotransferases; Body Weight; Danazol; Double-Blind Method; Endometriosis; Europe; Female; Follow-Up Studies; Gonadotropin-Releasing Hormone; Humans; Nafarelin; Treatment Outcome

In most species, continuous administration of GnRH agonists desensitizes the pituitary to GnRH, and blocks ovarian function. The aim of this study was to assess the effects of a novel controlled release device containing azagly-nafarelin (Gonazon) to prevent puberty in young Beagle bitches (mean age: 4.88 +/- 0.32 months). Gonazon containing 18.5 mg azagly-nafarelin (n = 10) or a placebo implant (n = 10) was administered subcutaneously. Throughout the 1-year treatment, estrus behaviour was monitored weekly. Plasma progesterone concentrations, as well as body weight and height, were measured monthly. Following implant removal, estrus detection and progesterone measurement were continued until occurrence of puberty in all bitches. Control bitches displayed puberty (estrus, followed by ovulation) at approximately 11.9 +/- 2.7 (range, 8-16) months of age. In contrast, none of the Gonazon treated bitches displayed puberty during the period when Gonazon was present. Following removal of Gonazon, resumption of estrus and ovulation naturally occurred (seven bitches) or was induced (three bitches) approximately 8.5 (1.2-14.3) months later. As a consequence, age of puberty of the Gonazon treated bitches was 25.5 +/- 5 (18-31) months. No clinically detectable side effects were noted in Gonazon treated bitches. Height at withers was unaffected by treatment. Changes in body weight with time were also unaffected by treatment. Implants were well tolerated and generally easy to remove. These data demonstrated that Gonazon safely, efficiently and reversibly prevents reproductive function for 1 year in prepubertal bitches.

Topics: Animals; Body Weight; Chi-Square Distribution; Dogs; Drug Implants; Female; Gonadotropin-Releasing Hormone; Nafarelin; Progesterone; Random Allocation; Sexual Maturation

Polycystic ovary syndrome (PCOS) is characterized by various endocrine and metabolic abnormalities, whose mutual associations and symptoms are still not clear. In the present study, fifteen PCOS patients and fifteen controls, matched for age and body weight, were investigated. Endocrine profiles were evaluated by the nafarelin and the adrenocorticotropin (ACTH) test. Insulin sensitivity was determined by an intravenous insulin tolerance test. Patients showed a significant predominance of abdominal adiposity [waist-to-hip ratio (WHR), 0.86 +/- 0.05 vs. 0.79 +/- 0.04] with markedly higher fasting insulin levels (+75%) and reduced insulin sensitivity (-37%). Fasting insulin, testosterone and free androgen index were positively correlated with the body mass index (BMI). In contrast, insulin sensitivity and BMI were inversely correlated in patients only. In the nafarelin test increases of 17-OH-progesterone and androstenedione were higher in patients and positively correlated with fasting insulin levels. Lipoprotein profiles showed trends towards higher triglycerides, lower HDL-cholesterol and a preponderance of small, dense LDL in patients. In PCOS higher triglycerides and lower HDL cholesterol were correlated with insulin sensitivity. It is concluded that PCOS patients show metabolic abnormalities combined with a more adroid type of adiposity when compared to cyclic controls of similar BMI.

Topics: 17-alpha-Hydroxyprogesterone; Adipose Tissue; Adrenal Glands; Adult; Androstenedione; Body Composition; Body Constitution; Body Mass Index; Body Weight; Cholesterol, HDL; Fasting; Female; Humans; Insulin; Insulin Resistance; Lipoproteins; Lipoproteins, LDL; Nafarelin; Ovary; Polycystic Ovary Syndrome; Testosterone; Triglycerides

The purpose of this study was to compare the lumbar bone mineral density (BMD) between women with endometriosis and age-similar controls. Eighty-five women from nine North American centers (mean age, 30.7 yr) with laparoscopically proven endometriosis (study patients) were enrolled in a study of the efficacy of nafarelin, a GnRH agonist. Fifty-two women (mean age, 32 yr) from the Palo Alto area, with regular menstrual cycles and no major medical problems, served as age-similar controls. Both groups were predominantly (greater than 92%) white. The mean BMD of the lumbar spine was 1.1 g/cm2 in both the study subjects and the controls. Study patients were 104.8% and controls were 104.8% of normal values for age. BMD was not significantly different in the two groups. BMD was not correlated with severity or time from diagnosis of endometriosis. BMD was positively correlated with weight (r = 0.28; P less than 0.05) in both groups, with height (r = 0.30; P less than 0.01) in study patients, and marginally with height (r = 0.26; P less than 0.07) in controls. This study showed no difference in BMD between endometriosis patients and age-similar controls; both groups had normal BMD.

Topics: Adolescent; Adult; Alcohol Drinking; Body Weight; Bone Density; Calcium; Diet; Endometriosis; Exercise; Female; Gonadotropin-Releasing Hormone; Humans; Lumbar Vertebrae; Middle Aged; Nafarelin; Smoking