Study: Progesterone Therapy May Improve COVID-19 Outcomes for Men

New research from Cedars-Sinai Medical Center found that progesterone may improve clinical outcomes for certain hospitalized men with COVID-19.

The plot clinical trial included 40 men and is believed to be the first published study to use progesterone to treat male COVID-19 patients whose lung functions have been compromised by the virus, according to the authors.

“As an ICU doctor, I was struck by the gender disparity among COVID-19 patients who were very sick, remained in the hospital and needed ventilators,” said principal study investigator Sara Ghandehari, MD, director of Pulmonary Rehabilitation in the Women’s Lung Institute, in a press release.

Ghandehari added that some published research had indicated that premenopausal women, who generally have higher progesterone levels, had less severe COVID-19 disease than did postmenopausal women, who have lower progesterone levels. Although the bodies of both men and women naturally produce progesterone, women produce much more of the hormone during their reproductive years, according to the study.

During the clinical trial, conducted from April 2020 to August 2020, 40 patients who were hospitalized with moderate to severe COVID-19 were randomly assigned to 1 of 2 groups. The control group received the standard medical care at the time for the disease, whereas the experimental group received standard care plus twice-daily injections of 100 milligrams of progesterone for 5 days while they were hospitalized. Additionally, both groups were assessed daily for 15 days or until they were discharged from the hospital.

The findings showed that compared with the control group, patients in the groups treated with progesterone scored a median 1.5 points higher on a standard 7-point scale of clinical status after 7 days. The scale ranged from a high of 7 (“not hospitalized, no limitations on activities”) to 1 (“death”). Although the progesterone group overall also had fewer days of hospitalization and a lower need for supplemental oxygen and mechanical ventilation, the differences between the 2 groups in those specific categories were not statistically significant, according to the study authors.

There were no serious adverse events, including life-threatening events, attributable to progesterone administration; however, there were 2 deaths (1 in each group) during the 15-day study period, neither of which was attributable to progesterone, according to the study authors.

"While our findings are encouraging for the potential of using progesterone to treat men with COVID-19, our study had significant limitations," Ghandehari said in a press release.

Limitations of the study include the relatively small sample size, mainly white, Hispanic, and obese patients with a moderate burden of comorbidities, and the clinical trial’s unblinded approach.

"Further research is necessary in larger, more heterogeneous populations, including postmenopausal women and at other treatment centers, to establish the degree of clinical efficacy and to assess any other potential safety concerns of this treatment approach," Ghandehari said in a press release.

REFERENCE

Study: progesterone therapy may improve COVID-19 outcomes for men. Cedars-Sinai. Published March 18, 2021. Accessed March 23, 2021. https://www.cedars-sinai.org/newsroom/study-progesterone-therapy-might-improve-covid-19-outcomes-for-men/.