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

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.

Chinese abstract

目的: 本研究主要目的为评估围绝经期女性每月应用非高分子微球性17β雌二醇(E)/孕酮(P)肠外制剂治疗围绝经期症状和生存质量的短期效果。

方法: 对一项多中心, 随机, 单盲研究进行二次分析。该研究分别对不同组别的围绝经期和绝经后期女性每月肌内注射0.5mg E + 15mg P(A组, n = 34), 1mg E + 20mg P(B组, n = 24)及1mg E + 30mg P (Group C, n = 26), 共计6个月。应用Greene围绝经期量表(GCS)和Unitan生存质量量表(UQoLS)以评估治疗前后围绝经期症状程度和生存质量。

结果: 在完成6个月治疗后所有组别的GCS分数均低于治疗前, 证明受试女性的围绝经期症状有所改善。同样, 所有组别UQoL分数高于6个月前证明受试女性的生存质量总体得到改善; 但仅有情感领域分数(组A和B) 和职业领域分数(组C)有意义。

结论: 连续3个月低剂量肌内注射E/P微球对围绝经期症状和生存质量的改善起到积极作用。长期效果有待观察。

临床试验登记号: Clinicaltrials.gov Identifiers NCT 00775242

Keywords:

• Climacteric
• estradiol
• Greene Climacteric Scale
• menopausal symptoms
• non polymeric microspheres
• quality of life
• Utian Quality of Life Scale

Declaration of interest

The authors report no conflicts of interest and are responsible alone for the content and writing of this document. This research was funded by Productos Científicos, S.A. de C.V. (Carnot Laboratories, Ciudad de México, México).