Effectiveness, tolerability and acceptance of an oral estradiol/levonorgestrel formulation for the treatment of menopausal complaints: a non-interventional observational study over six cycles of 28 days

Abstract

Background: Use of hormone therapy for menopausal complaints is a subject of controversy and increased uncertainty and concerns. This non-interventional study aimed to investigate a marketed oral formulation containing 1 mg estradiol and 0.04 mg levonorgestrel for continuous treatment of menopausal symptoms for approximately 6 months in women visiting gynecological practices in Germany.

Methods: Changes in the menopause rating scale (MRS) total and sub-domain scores after three and six 28-d cycles served as primary endpoint. Skin- and hair-related complaints, quality of sexual life and subjective satisfaction with the treatment were assessed. Adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding were evaluated.

Results: MRS scores improved significantly above 5 points of clinical relevance as compared to baseline (n = 736, p < 0.0001). Skin- and hair-related symptoms abated; quality of sexual life improved. AEs were registered in 9.9% of the participants. No unexpected ADRs were reported. Bleeding episodes consistently decreased; >75% of the subjects were amenorrheic throughout the study. Medication's effectiveness and tolerability was rated very good/good by >80% of the participants, who also continued treatment.

Conclusion: This estradiol/low-dose levonorgestrel formulation safely alleviates menopausal symptoms in peri- and postmenopausal women with add-on benefits regarding dermatological and sexual life complaints.

Chinese abstract

背景：采用激素治疗女性更年期不适是一项有争议的课题，且其不确定性和患者的忧虑在增加。这项非干预性研究旨在探讨一种已上市的口服剂型（含1mg雌二醇和0.04mg左炔诺孕酮）的治疗效果。在德国妇科门诊中，已采用该剂型对有更年期症状的女性连续治疗6个月。

方法：以28天为一个周期，将3个和6个周期后绝经评定量表（MRS）的总分和区域得分的变化作为主要终点。治疗后评估皮肤和毛发相关的不适症状、性生活质量及主观满意度。同时对药物不良反应（ADRs）、不良事件（AEs）和阴道出血进行评价。

结果：与基线水平（n=736, p<0.0001）相比，MRS得分显著提高了5个点以上临床相关性。治疗后皮肤和毛发的不适症状减轻；性生活质量提高。参加者中有9.9%记录发生了不良事件。未报道出现意外不良反应。出血发生率一致降低；整个研究中超过75%的受试者出现闭经。80%以上的参加者对药物的有效性和耐受性评价很好/好，这些参加者将继续接受治疗。

结论：这种雌二醇/低剂量左炔诺孕酮剂型较安全地缓解了围绝经期及绝经后女性的更年期症状，同时在皮肤不适和性生活满意度等方面带来了其他益处。

• Estradiol/levonorgestrel
• menopausal hormone therapy
• menopause
• menopause rating scale
• non-interventional study

Acknowledgements

We are indebted to the health care providers and all study participants for their contribution. We owe special thanks to our colleague Ernesta Palombo-Kinne for medical review of data and review of the clinical study report.