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A total of 188 non-pregnant women with hyperprolactinemia (whose prolactin levels were >20 ng/mL, the upper limit of the normal reference range) were enrolled in Study 1. The etiologies of their hyperprolactinemia were as follows: macroprolactinoma (60%, n=113), idiopathic (36%, n=67), and other causes (4%, n=8). The mean age of the patients was 32 years (range: 16–46 years); 99% were White (n=186), 0.5% were Asian (n=1), and 0.5% were of other races (n=1).
Patients were randomly assigned to receive one of the following five oral treatments, administered twice weekly for four weeks (for the DOSTINEX group, a lower dose of DOSTINEX was used in the first week to reduce the risk of hypotensive reactions):
Group 1: Placebo, twice weekly (n=20).
Group 2: 0.0625 mg DOSTINEX twice weekly in the first week, followed by 0.125 mg twice weekly for the subsequent three weeks (n=42) — This dose is not recommended as it was ineffective, and the results of this group are not presented below.
Group 3: 0.25 mg DOSTINEX twice weekly in the first week, followed by 0.5 mg twice weekly for the subsequent three weeks (n=42)
Group 4: 0.375 mg DOSTINEX twice weekly in the first week, followed by 0.75 mg twice weekly for the subsequent three weeks (n=42)
Group 5: 0.5 mg DOSTINEX twice weekly in the first week, followed by 1 mg twice weekly for the subsequent three weeks (n=42)
In Study 1, the endpoint was the percentage of patients who achieved normal serum prolactin levels (<20 ng/dL) at the end of the 4-week treatment period. At Week 4, 0%, 76%, 74%, and 95% of patients in the placebo group (Group 1), Group 3, Group 4, and Group 5, respectively, achieved normal serum prolactin levels (all DOSTINEX groups vs. placebo group, p < 0.0001).
FDA，2025.04
