Introduction: Endometriosis is an inflammatory, chronic, debilitating, high-incidence condition with serious consequences for women's reproductive, quality of life and sexual health.
Objective: To determine the efficacy and safety of drospirenone when compared to Dienogest / Estradiol Valerate, in the treatment of endometriosis pain, and its influence on sexual function.
Materials and Methods: A randomized, controlled, triple-blind, multicenter clinical trial. We included 185 women, aged 18 to 39, diagnosed with endometriosis. In fifteen institutions of medium and high complexity, in the Eje Cafetero, Colombia. 94 were administered drospirenone (DRSP) (experimental group), and 91 received Dienogest / Estradiol Valerate (VE/DNG) (control group); between 2020 and 2025. They were followed up three times, every 8 weeks. Descriptive statistics were performed.
Outcomes: At 24 weeks, pain relief was observed in both groups: 75.53% (DRSP) and 71.42% (VE/DNG) (p>0.05). The decrease in pain was accompanied by an improvement in sexual function, with increased sexual desire, excitation/lubrication in both groups (p>0.05). Regarding adverse effects, no significant differences were observed between groups (24.46% versus 20.87%; p = 0.81), whose intensity was considered “mild” by the patients. There was no superiority or inferiority of DRSP versus the combination of VE/DNG in efficacy, safety, tolerability, and satisfaction (p>0.05).
Conclusions: DRSP is effective for the treatment of endometriosis pain, and it is similar to the combination of VE/DNG, with no significant difference in incidence of adverse effects. More randomized clinical trials evaluating the positive influence of drospirenone are required.