Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients

• Status: Completed
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this randomized placebo-controlled study is to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease.

The main question[s] it aims to answer are:

• the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease

• the biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease

All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time.

As an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days.

Researchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of Covid-19 disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)
• Collaborators: Karakoy Rotary Club; Rebul Pharmacy; Turkish Menopause and Osteoporosis Society
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Female patients diagnosed with Covid-19 disease

• Postmenopausal women (who had 12 months of amenorrhea after their final menstrual period)

• Positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs

Exclusion Criteria:

• Negative RT-PCR test

• Female patients at reproductive stage