TOLERABILITY, SAFETY AND EFFICACY OF 2 FORMULATIONS OF PARLODEL(R) - A SLOW-RELEASE ORAL FORM (SRO) VERSUS REGISTERED PARLODEL CAPSULES

Twenty hyperprolactinemic patients who entered a randomized parallel-g roup, double-blind, double-dummy study were investigated regarding saf ety, tolerability and efficacy. Half of the patients received 5 mg Par lodel(R) SRO plus placebo for Parlodel while the other half received 2 .5 mg Parlodel b.i.d. and placebo for Parlodel SRO for a period of 15 days. In the second following period of 15 days, the daily dose was in creased to 10 mg Parlodel administered either as a single dose of Parl odel SRO or two doses of Parlodel 5 mg. The plasma prolactin levels, c linical signs and symptoms of hyperprolactinemia, physical examination , blood pressure, heart rate assessments and adverse events were recor ded during the study. Complete blood count, blood chemistry and standa rd ECG were performed before and at the end of treatment. In conclusio n, both formulations are equally efficacious, well tolerated and safe. Due to the comfort of once-a-day administration and the excellent com pliance, one could recommend to replace the b.i.d. or t.i.d. administr ation of Parlodel with the once-a-day Parlodel SRO in hyperprolactinem ic patients.