Adverse events generally have been mild: vaginal spotting, vaginal discharge, allergic reaction and skin rash. Adverse events with an incidence of 5% or greater are reported for two comparative trials. Data for patients receiving either VAGIFEM or placebo in the double blind study are listed in Table 5, and data for patients receiving VAGIFEM in the open label comparator study are listed in Table 6.

Table 5: ADVERSE EVENTS REPORTED IN 5% OR GREATER NUMBER OF PATIENTS RECEIVING VAGIFEM® IN THE PLACEBO CONTROLLED TRIAL.

Table 6: ADVERSE EVENTS REPORTED IN 5% OR GREATER NUMBER OF PATIENTS RECEIVING VAGIFEM® IN THE OPEN LABEL STUDY.

Other adverse events that occurred in 3-5% of VAGIFEM subjects included: allergy, bronchitis, dyspepsia, haematuria, hot flashes, insomnia, pain, sinusitis, vaginal discomfort, vaginitis. A causal relationship to VAGIFEM has not been established.

Drug/Laboratory Test Interactions

Certain endocrine and liver function tests may be affected by estrogen-containing oral contraceptives. The following similar changes may be expected with larger doses of estrogens:

1. Increased prothrombin and factors VII, VIII, IX, and X, decreased antithrombin III; increased nore-pinephrine induced platelet aggrega-bility.
2. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by PBI, T4 by column, or T4 by radioimmunoassay. Free T4 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.
3. Impaired glucose tolerance. d. Reduced response to metyrapone test. e. Reduced serum folate concentration. f. Increased serum triglyceride and phospholipid concentration.

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