A double-blind placebo-controlled trial of
progesterone vaginal suppositories in the
treatment of premenstrual syndrome.
Maddocks S, Hahn P, Moller F, Reid RL.
Rigorous criteria were used to select women with
severe premenstrual syndrome for inclusion in an
8-month double-blind placebo-controlled clinical
trial of progesterone vaginal suppositories.
Following a control month without treatment,
progesterone (200 mg in polyethylene glycol
base) or placebo was self administered twice
daily by vaginal suppository for a minimum of 12
days before the onset of menstruation for 3
months. Crossover to the opposite medication for
a further 3 months was followed by a final
control cycle without treatment in month 8.
Physician contact was minimized throughout the
study to avoid any possible positive effects of
psychological support which may have confounded
past investigations. Detailed self-report
questionnaires were completed every 3 days for
the duration of the study. Although the
attrition rate was high, 20 women completed the
trial and their records are analyzed here. The
results of this trial indicate that the response
to vaginal progesterone in these dosages is, at
best, marginal and not significantly different
from response with placebo use.
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