Superiority of newly developed vaginal suppositories over vaginal use of commercial bromocriptine tablets: a randomized controlled clinical trial.

The objective of this study is to verify the safety and efficacy of new vaginal bioadhesive suppositories as compared with vaginal use of commercial bromocriptine tablets in hyperprolactinemic patients. This study is a randomized, double-blind, active comparator clinical trial in which a subset of patients had some pharmacokinetic measurements. The setting was an outpatient private infertility clinic in a developing country, and the subjects were 171 patients with hyperprolactinemia. A pilot phase comprised 32 patients who were divided into 2 groups. Group A comprised 16 patients who used vaginal suppositories containing 2.5 mg bromocriptine mesthylate with pluronics and bioadhesive agents once daily for 1 month, while group B included 16 patients who used commercial 2.5-mg bromocriptine mesthylate tablets inserted vaginally once daily for 1 month. The clinical phase comprised 139 patients who were again divided into 2 groups in the same way (group A, 68 patients; group B, 71 patients). Serum prolactin (SP) was measured before and after therapy in all cases. The main outcome measure was the decline of SP level after 1 month of therapy. In both groups, there was a significant decline of the SP. However, it was more significant in group A. Patient convenience was more evident, and local side effects were less in group A than group B in the clinical phase. The introduction of bioadhesive technology for bromocriptine mesylate/pluronic F-126 administration is valuable in achieving prominent serum prolactin reduction in hyperprolactinemic patients in a relatively short duration of therapy. The formulated vaginal suppositories expressed better convenience with minimal local side effects when compared with vaginally administered commercial bromocriptine tablets.