Effectiveness, tolerability and acceptance of a low-dosed estradiol/dienogest formulation (Lafamme 1 mg/2 mg) for the treatment of menopausal complaints: a non-interventional observational study over 6 cycles of 28 days

Abstract

Background: Concern and controversy characterize nowadays the use of hormone therapy for management of patients with menopausal complaints. This observational non-interventional study examined the use of a marketed oral formulation containing 1 mg estradiol valerate and 2 mg dienogest for treatment of menopausal symptoms in 1292 women visiting 243 gynecological practices in Germany.

Methods: Score changes in the Menopausal Rating Scale (MRS) after three and six 28-day cycles were primary endpoints. Subjective reports on skin- and hair-related complaints and satisfaction with treatment effects were assessed. The incidence of adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding was evaluated.

Results: MRS total score decreased substantially and stronger than the clinically relevant change of 5 points (p < 0.0001) as compared with baseline. Subjective skin- and hair-related complaints declined. No unexpected ADRs were reported. AEs (including ADRs) were registered in 8.8% of the participants; most frequent AEs/ADRs were postmenopausal hemorrhage (2.9%) and drug ineffective (1.4%). Nearly 76% of the subjects remained amenorrheic. Approximately 90% of the patients rated the medication’s effectiveness/tolerability as good/very good; 84% intended to continue the treatment.

Conclusion: This low-dose estradiol/dienogest formulation proved efficient and well-tolerated option for the alleviation of menopausal symptoms associated with estrogen deficiency.

• Estrogens
• hormone replacement therapy
• menpopause
• Menopause Rating Scale
• progesterone

Acknowledgements

We are indebted to the health care providers and all study participants for their contribution. We owe special thanks to our colleagues Ernesta Palombo-Kinne for the medical review of study data and Kerstin Gude for the critical review of the manuscript.

Declaration of interest

The authors performed the study being employed by the sponsor Jenapharm GmbH & Co. KG.

Notes

¹The presence of such subjects in the patient collective is owing to the observational character of the study.