Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17β-estradiol/progesterone

• Published in: Gynecological endocrinology Vol. 32; no. 10; pp. 831 - 834
• Main Authors: Cortés-Bonilla, Manuel, Alonso-Campero, Rosalba, Bernardo-Escudero, Roberto, Francisco-Doce, María T., Chavarín-González, Juan, Pérez-Cuevas, Ricardo, Chedraui, Peter
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 02-10-2016
• Subjects: Adult; Aged; Climacteric; estradiol; Estradiol - administration & dosage; Estradiol - pharmacology; Female; Gonadal Steroid Hormones - administration & dosage; Gonadal Steroid Hormones - pharmacology; Greene Climacteric Scale; Humans; Injections, Intramuscular; menopausal symptoms; Menopause - drug effects; Microspheres; Middle Aged; non polymeric microspheres; Progesterone - administration & dosage; Progesterone - pharmacology; Quality of Life; Single-Blind Method; Treatment Outcome; Utian Quality of Life Scale; Utian Quality of Life Scale; Climacteric; non polymeric microspheres; quality of life; Greene Climacteric Scale; estradiol; menopausal symptoms
• ISSN: 0951-3590; 1473-0766
• DOI: 10.1080/09513590.2016.1183628

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.