Figure 1.
Flow Diagram Of Healthy Early Postmenopausal Participants Through The Cardiovascular Assessment Portion Of The Progesterone For Hot Flushes Randomized Controlled Trial.
This shows those excluded before randomization for abnormal historical or physical examination results, those secondarily excluded because of laboratory abnormalities and those randomized to progesterone or placebo arms. Also indicated are those with analyzable venous occlusion plethysmography assessment of the endothelial function effects of progesterone or placebo, morphometric, blood pressure, lipid and inflammation data.
Table 1.
Baseline Characteristics Of Venous Occlusion Plethysmography Participants In This Controlled Trial Of Oral Micronized Progesterone (Progesterone) Therapy For Vasomotor Symptoms.
Figure 2.
Endothelial Function on Progesterone or Placebo.
Forearm venous occlusion plethysmography was performed in 34 healthy early postmenopausal women in a randomized, placebo-controlled trial of oral micronized progesterone (300 mg, Progesterone) for hot flushes. This plot shows dose responses in forearm blood flow (FBF) to intra-brachial artery infusions of vasodilators: A. nitric oxide-releasing, endothelium-dependent (acetylcholine - ACh); B. endothelium-independent (sodium nitroprusside - SNP). Data are mean ± SE of percentage (%) increase in FBF above saline baseline for those randomized to Progesterone (n = 18) and Placebo (n = 16). The 15% increase in FBF at each dose of ACh during Progesterone therapy was not statistically significant.
Table 2.
Endothelial Function Responses On Oral Micronized Progesterone (Progesterone) Or Placebo In This Randomized Controlled Trial Of Oral Micronized Progesterone (Progesterone) For Short-term Effects On The Cardiovascular System.
Table 3.
Cardiovascular System Marker Changes During A 12-Week Randomized Controlled Trial Of Oral Micronized Progesterone (Progesterone) For Effects On The Cardiovascular System.
Figure 3.
Changes in Lipids on Progesterone or Placebo.
These graphs show dot plots of lipid changes in 108 healthy early postmenopausal women in a randomized controlled trial of oral micronized progesterone (Progesterone, 300 mg daily) for hot flushes between the 4-week run-in and the 12 weeks of experimental therapy. Women were randomized in a 1∶1 ratio to Progesterone (n = 63) or Placebo (n = 45). The median change is shown with a line of stars. A. Total Cholesterol changes—not different by therapy; B. High density lipoprotein cholesterol = HDC-C—the level during Progesterone therapy was significantly lower (−0.14 mmol/L, p = 0.001)( 95% CI of difference, −0.20, −0.07); C. Low density lipoprotein cholesterol = LDL-C—not different by therapy; D. Triglycerides—not different by therapy.
Figure 4.
Changes in Framingham General Cardiovascular System Profile [26] 10-y Risk Score.
These data are from 108 untreated healthy postmenopausal women (1–11 years since their last menstrual flow) in a randomized controlled trial of oral micronized progesterone (300 mg daily, Progesterone; n = 63) or identical placebo (Placebo, n = 45) for treatment of hot flushes/flashes and night sweats. This pair of dot-plots shows women's Framingham General CVS Profile during run-in by assignment to Progesterone or Placebo (left panel) and at the end of 12-weeks of experimental therapy (right panel). None of these differences were statistically significant.