Article: A PROSPECTIVE, SINGLE-ARM CLINICAL EVALUATION OF PRINKWELLNESS VAGINAL SUPPOSITORIES IN THE MANAGEMENT OF PRIMARY DYSMENORRHEA

Article Category: Original Research articles

DOI: 10.7897/2277-4343.17112

Pages: 50-62

Author: K. Hemalatha, Nagarjuna Mummidi *, Srivatsa GS, Rajasekhar G

Abstract: Background: Primary dysmenorrhea is a common gynaecological condition associated with recurrent menstrual pain and reduced quality of life. Limitations of long-term systemic therapies have encouraged exploration of localized treatment options. Objective: To evaluate the safety and efficacy of Prinkwellness vaginal suppositories in the management of primary dysmenorrhea. Materials and Methods: This prospective, single-arm, open-label clinical study was conducted at a single center. A total of 100 women aged 18–50 years with primary dysmenorrhea were enrolled, and 90 participants completed the study. Prinkwellness vaginal suppositories were administered over two consecutive menstrual cycles at doses of 100 mg in the first cycle and 120 mg in the second cycle. Pain intensity was assessed using the Visual Analogue Scale (VAS) at Baseline (Day 0), Day 30, and Day 60. Health-related quality of life was evaluated using the Short Form-36 (SF-36) questionnaire at Day 30 and Day 60. Safety was assessed through monitoring of adverse events and treatment tolerability. Results: Mean VAS pain scores decreased significantly from 8.02 ± 1.35 at Baseline to 1.68 ± 0.89 at Day 60 (p < 0.0001). Improvements were observed across multiple SF-36 domains. No serious adverse events were reported. Conclusion: Prinkwellness vaginal suppositories were associated with significant reduction in menstrual pain and improvement in quality of life, with a favourable safety and tolerability profile.

Keyword: Primary dysmenorrhea, Menstrual cramps, Vaginal suppositories, Visual Analogue Scale, Quality of life, SF-36.