Study to Evaluate the Efficacy and Safety of Dexketoprofen / Butylscopolamine vs Dexketoprofen in Treatment of Primary Dysmenorrhea

This study seeks to evaluate the efficacy and safety of the fixed dose combination of dexketoprofen/butylscopolamine compared to dexketoprofen for the treatment of primary dysmenorrhea in 130 mexican women.

Inclusion Criteria: 1. Female, 18 to 35 years of age. 2. Agrees to participate in the study by signing the Informed Consent Form. 3. History of a diagnosis of primary dysmenorrhea, characterized as colicky lower abdominal pain during menstruation, present for at least 3 consecutive menstrual cycles, lasting between 4 hours and 4 days, not associated with underlying pathology, and with onset before the age of 18. 4. Presence of regular menstrual cycles (in accordance with international guidelines and consensus, a regular menstrual cycle is defined as one lasting between 21 and 35 days, with bleeding usually lasting between 2 and 7 days) during the 6 months prior to study enrollment, as reported by the patient during direct questioning. 5. History of pain secondary to dysmenorrhea with an intensity of ≥50 mm on the Visual Analog Scale during the 3 menstrual cycles prior to study enrollment, as reported by the patient during direct questioning. 6. Willing and able to comply with scheduled visits and the study treatment plan, as confirmed by the patient during direct questioning. 7. In the opinion of the Principal Investigator or treating physician, is indicated for treatment with the investigational product and is likely to derive clinical benefit. 8. Agrees to use one of the following barrier methods: diaphragm, cervical cap, male condom, female condom, foam, sponge, or spermicidal film. Exclusion Criteria: 1. Patients participating in another clinical trial involving an investigational treatment, or who have participated in one within the 2 weeks prior to the start of the study. 2. Patients whose participation in the study could be influenced (employment relationship with the research center or sponsor, vulnerable populations, etc.). 3. At the physician's discretion, a disease affecting prognosis and preventing outpatient management; this must be evaluated by the principal investigator to determine the appropriateness of the subject's inclusion in the study. 4. History of a diagnosis of secondary dysmenorrhea (determined via direct questioning of the patient or transvaginal/pelvic ultrasound performed within the last 3 months). 5. Allergy or hypersensitivity to the study medications or any of their excipients (dexketoprofen and butylscopolamine). 6. History of bronchospasm, rhinitis, asthma, urticaria, or edema associated with the use of aspirin or any NSAID. 7. Medical or surgical history suggesting the presence of endometriosis, uterine fibroids (myomatosis), ovarian cysts, adenomyosis, or polycystic ovary syndrome, as well as sexually transmitted diseases and/or pelvic inflammatory disease. 8. Current or recent use of medications that could affect pain scores, such as hormonal contraceptives (within the previous 3 months) or other NSAIDs (within the previous 72 hours). 9. History of chronic dyspepsia, peptic ulcer, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, etc. 10. Pregnancy, breastfeeding, or the postpartum period (less than 6 months). 11. Current or recent use (within the previous 3 months) of antidepressants or anxiolytics. 12. Use of a copper intrauterine device (IUD). 13. History of occasional excessive alcohol consumption (more than 4 standard drinks per day for women) and drug use.