Assuntos
Endometriose/tratamento farmacológico , Gestrinone/uso terapêutico , Norpregnatrienos/uso terapêutico , Administração Intravaginal , Administração Oral , Ensaios Clínicos como Assunto , Implantes de Medicamento , Feminino , Gestrinone/administração & dosagem , Gestrinone/efeitos adversos , HumanosRESUMO
A prospective randomized study was conducted in 100 women with leiomyomas in order to evaluate the effect of gestrinone, a synthetic derivative of ethynil-nor-testosterone. Patients in group A received capsules containing 2.5 mg of gestrinone three times weekly orally. Those in group B received capsules containing 5.0 mg twice weekly, also orally. In group C, patients used by vaginal route tablets containing 5 mg of gestrinone three times weekly. Reduction in uterine volume occurred in all three groups of patients. Of patients who discontinued treatment at 6 months, uterine volume remained lower than pretreatment values in 89%, 18 months after discontinuation. Of those patients who discontinued at 1 year, uterine volume remained below pretreatment levels in 76% 1 year after discontinuation. In patients treated continuously for 24 months, mean uterine volume decreased from a mean 339 cm3 to 273 cm3, a statistically significant difference. The vaginal route showed statistically more significant volume decreases than the oral route for all treatment intervals.
Assuntos
Gestrinone/uso terapêutico , Leiomioma/tratamento farmacológico , Norpregnatrienos/uso terapêutico , Neoplasias Uterinas/tratamento farmacológico , Administração Intravaginal , Adulto , Ensaios Clínicos como Assunto , Esquema de Medicação , Feminino , Gestrinone/administração & dosagem , Humanos , Leiomioma/diagnóstico , Gravidez , Estudos Prospectivos , Distribuição Aleatória , Ultrassonografia , Neoplasias Uterinas/diagnósticoRESUMO
In a study involving over 300 women, gestrinone has been found to induce regression of uterine myomas. Gestrinone was given in doses of 2.5-5 mg (orally or by vaginal pessary), two or three times weekly. The treatment regimen depended upon tumor size and tumor age. Patients with small tumors, i.e. uterine volumes of less than 200 cm3, were treated for 6 months, whereas those with uterine volumes of 200-300 cm3 were treated for 1 year. In severe cases where uterine volumes were greater than 400 cm3, the patients were treated for 2 years. Large myomas of 300 cm3 or more required higher doses of steroid. During the first 6 months of treatment there was a marked reduction in uterine volume, but subsequently the rate of tumor regression was slower. Following discontinuation of treatment, reactivation of tumor growth was slow in most patients. Gestrinone caused amenorrhea in all patients and in most women it lasted throughout therapy. The abdominal discomfort, dyspareunia and dysuria which resulted from the myoma were progressively alleviated during treatment. Most patients experienced at least some side-effects associated with the mild androgenicity of gestrinone. These included weight gain, seborrhea and acne (which developed in most patients). Hirsutism, hoarseness and increase in libido were less common, affecting 10-20% of patients, depending on the dose and duration of treatment. All side effects were reversible.