Rectal versus vaginal bromocriptine mesylate suppositories in hyperprolactinemic patients: an active comparator trial

Objectives: to compare the clinical effectiveness, side effects and tolerability of rectal versus vaginal bromocreptine/pluronic F-127suppositories as compared to oral bromocriptine tablets for treating pathologic hyperprolactinemia.
Design: An active comparator randomized study.
Setting: A pharmaceutical phase at the department of Pharmaceutics, Faculty of Pharmacy, and a clinical phase at the Infertility out-patient Clinic of the department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University.
Materials and methods: A total of 69 female and 3 male patients with pathologic hyperprolactinemia. The 69 female patients were randomly divided into 3 groups. Group A comprised 22 patients who used rectal suppositories once daily for one month. Group B included 20 patients who used vaginal suppositories once daily for one month. Group C comprised 27 patients who received 2.5 mg bromocriptine tablets twice daily for one month. Serum prolactin (SP) was measured before and after therapy in all cases. The 3 males used the drug rectally daily for one month.
Main outcome measures: Decline of SP level after one month of therapy.
Results: The pharmaceutical phase of the study (group A and B) showed a higher but insignificant release rate constant (k) min-1 of the rectal than vaginal suppositories (0.60 vs. 0.51). In the clinical phase of all groups, there was an evident decline of SP levels after one month of therapy. Rectal application was associated with minimal local or systemic side effects. All the three males showed marked SP decline after therapy.
Conclusions: The approached bromocriptine suppositories containing pluronic F127 were proven to be effective in lowering SP whether used vaginally or rectally as compared to oral treatment. Rectal approach has minimal side effects, it is more convenient for patients who don’t accept to manipulate the vagina especially virgins, others fail to use the drug during menstruation, or during the postabortive or postpartum periods and those patients who believe that the drug may affect their fertility by interfering with sexual relationship. Furthermore, it can be used by intolerant hyperprolactinemic males. Its use as an alternative non-oral approach should be considered during counseling of patients in those formerly mentioned situations.