Dr Anita Townsend1, Dr Pedro-Antonio Regidor2, Dr Elena Rojas2, Dr Alycioy Angulo2, Dr Enrico Colli2
1Besins Healthcare Australia, Sydney, Australia, 2Exeltis Pharmaceuticals, Madrid, Spain
Biography:
Anita Townsend PhD (King's College London) is Senior Medical Advisor at Besins Healthcare Australia, with extensive experience in women’s health, including menopause, contraception, fertility, and hormone therapy. Her work focuses on evidence generation, medical education, and regulatory‑aligned clinical communication.
Aims:
Evaluate bleeding/spotting days and amenorrhoea with a novel 24+4 drospirenone (DRSP)-only oral regimen versus placebo in women with endometriosis.
Methods:
Women aged 15–45 years with confirmed endometriosis were randomised (3:1) to DRSP 4 mg for 24 days plus DRSP 2.8 mg for 4 days, or placebo, for 3 double-blind cycles, then 3 open-label DRSP cycles. Bleeding/spotting was recorded daily; endpoints included amenorrhea and scheduled vs unscheduled bleeding (mFAS N=211; PP N=188).
Results:
During double-blind treatment, DRSP reduced bleeding/spotting versus placebo and increased the proportion with no bleeding/spotting (25.9% vs 2.2%). After 6 DRSP cycles, amenorrhea was reported in 42.3% of continuous-DRSP participants and 31.6% of patients switched from placebo. Scheduled bleeding decreased; early-cycle unscheduled spotting was more common with DRSP but was mostly mild and declined over time. Discontinuations due to bleeding-related adverse events were low and similar (1.2% DRSP vs 1.9% placebo) during the double-blind phase.
Conclusions:
A DRSP 4 mg/2.8 mg 24+4 regimen provided effective menstrual suppression in endometriosis, reducing bleeding days and achieving substantial amenorrhea rates over 6 cycles. Mild, transient early spotting did not increase discontinuations, supporting favourable bleeding tolerability.
Clinical Trial Registration:
EudraCT 2021-001424-179.