Effects of Progesterone on Vasomotor Symptoms in Postmenopausal Women (PROGEST) - a Prospective Multi-Center...

Area of Science:

• Reproductive Medicine
• Pharmacology

Background:

• Vasomotor symptoms (VMS) are common in postmenopausal women.
• Progesterone monotherapy has shown efficacy in treating VMS in previous trials.
• The PROGEST-trial aimed to meet FDA approval criteria for VMS treatment.

Purpose of the Study:

• To evaluate the efficacy and safety of different doses of oral micronized progesterone for treating moderate to severe VMS in postmenopausal women.
• To compare oral micronized progesterone against a placebo in a randomized, double-blind, placebo-controlled trial.

Main Methods:

• Prospective randomized, double-blind, placebo-controlled clinical trial.
• 12-week treatment duration with oral micronized progesterone (200mg, 300mg, 400mg) or placebo daily.
• Screening for VMS frequency (over 50 per week) before randomization.

Main Results:

• 74 women were recruited; 44 completed the study as per protocol.
• A slight dose-dependent decrease in VMS was observed across progesterone groups compared to placebo.
• 32 treatment-emergent adverse events were documented in 18 participants; one serious adverse event (syncope) occurred.

Conclusions:

• The study was prematurely discontinued due to insufficient subject accrual, resulting in limited statistical power.
• Despite limitations, a slight dose-dependent improvement in VMS was observed with oral micronized progesterone.
• Adverse event frequency did not correlate with increasing progesterone dosage.