Manuel Cortés-Bonilla1, Rosalba Alonso-Campero2, Roberto Bernardo-Escudero2, María T Francisco-Doce2, Juan Chavarín-González2, Ricardo Pérez-Cuevas3, Peter Chedraui4. 1. a Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes" , Ciudad de México , México. 2. b Centro A.F. de Estudios Tecnológicos , S.A. de C.V. (CAFET), Ciudad de México , México. 3. c Unidad de Investigación Epidemiológica y en Servicios de Salud, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social , Ciudad de México , México , and. 4. d Facultad de Ciencias Médicas , Instituto de Biomedicina, Área de Investigación para la Salud de la Mujer, Universidad Católica de Santiago de Guayaquil , Guayaquil , Ecuador.
Abstract
OBJECTIVE: To evaluate the short term effect over menopausal symptoms and quality of life (QoL) of monthly parenteral formulations of 17β-estradiol (E)/progesterone (P) non-polymeric microspheres. METHODS: This is a secondary analysis of a multicenter, randomized, single-blinded study that included peri- and post-menopausal symptomatic women assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24), or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Intensity of menopausal symptoms was assessed before and after treatment with the Greene Climacteric Scale (GCS) and QoL with the Utian Quality of Life Scale (UQoLS). RESULTS:Menopausal symptoms improved for all groups at six months evidenced by lower cluster/sub-cluster GCS scores. Equally, there was an overall trend for QoL improvement for all groups evidenced by higher domain UQoLS scores at six months; but only significant for the emotional (Groups A and B) and occupational domains (Groups A and C). CONCLUSION: The three low-dose continuous sequential intramuscular monthly formulations of E/P microspheres exerted a positive effect over menopausal symptoms and QoL. Long-term research is warranted with these formulations. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov Identifiers NCT 00775242.
RCT Entities:
OBJECTIVE: To evaluate the short term effect over menopausal symptoms and quality of life (QoL) of monthly parenteral formulations of 17β-estradiol (E)/progesterone (P) non-polymeric microspheres. METHODS: This is a secondary analysis of a multicenter, randomized, single-blinded study that included peri- and post-menopausal symptomatic women assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24), or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Intensity of menopausal symptoms was assessed before and after treatment with the Greene Climacteric Scale (GCS) and QoL with the Utian Quality of Life Scale (UQoLS). RESULTS: Menopausal symptoms improved for all groups at six months evidenced by lower cluster/sub-cluster GCS scores. Equally, there was an overall trend for QoL improvement for all groups evidenced by higher domain UQoLS scores at six months; but only significant for the emotional (Groups A and B) and occupational domains (Groups A and C). CONCLUSION: The three low-dose continuous sequential intramuscular monthly formulations of E/P microspheres exerted a positive effect over menopausal symptoms and QoL. Long-term research is warranted with these formulations. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov Identifiers NCT 00775242.
Entities:
Keywords:
Climacteric; Greene Climacteric Scale; Utian Quality of Life Scale; estradiol; menopausal symptoms; non polymeric microspheres; quality of life