Clinical efficacy of novel unidirectional buccoadhesive vs. vaginoadhesive bromocriptine mesylate discs for treating pathologic hyperprolactinemia

Objective: To test the clinical effectiveness of new bioadhesive unidirectional buccal and vaginal bromocriptine methylate discs in hyperprolactinemic patients. Design: A preliminary randomized comparative study. Setting: A pharmaceutical phase at the departments of Pharmaceutics, Faculties of Pharmacy, Assiut and El-Minea universities and a clinical phase at the Infertility Out-patient Clinic of Women's Health University Center, Assiut University, Assiut, Egypt. Patient(s): A total of 42 patients with pathologic hyperprolactinemia. Intervention(s): Patients were randomly divided into two groups. Group A comprised 21 patients who used unidirectional buccoadhesive bromocriptine methylate discs once daily for 1 month. Group B included 21 patients who used vaginoadhesive bromocriptine methylate discs once daily for 1 month. Serum prolactin (PRL) was measured before and after therapy in all cases. Main Outcome Measure(s): Decline of serum PRL level after 1 month of therapy. Result(s): Pharmaceutically, tests for swelling, surface pH, in vitro and in vivo bioadhesion and in vitro release expressed satisfactory results. The in vitro release of vaginal bromocriptine from the discs is increased in pH 4.5 media. Both groups showed a highly statistically significant reduction of serum PRL levels after 1 month of therapy without any significant difference between both groups. The decline of serum PRL was not correlated with age, parity, or indication of entering into this study. Conclusion(s): Both buccoadhesive and vaginoadhesive discs containing bromocriptine are of equal efficacy for treating pathologic hyperprolactinemia. Buccoadhesive discs have the advantages of being gender nonspecific (i.e., could be used by men), avoiding manipulating the vagina, which could be inconvenient to some patients, such as virgins; not being dependent on cyclic estrogen (E) levels; and could be easily used during menstruation. (Fertil Steril((R)) 2008;90:1864-8. (c) 2008 by American Society for Reproductive Medicine.)