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Completed

NCT Number: NCT05774405

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

About this study

The risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, morbidity and mortality from Covid-19 disease were higher among men compared to women. This is caused by the differences in immunological response and viral pathogenesis between men and women. It is theoretically assumed that estrogen has a positive impact on female COVID-19 patients. In this randomized placebo-controlled study, we aimed to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease. Female patients diagnosed with Covid-19 disease were examined and only postmenopausal women were included into the study. The COVID-19 diagnosis was made with a positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs. 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.

Our primary outcome was to achieve better clinical and biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease. The epidemiological and clinical data, the results of biochemical analysis, the information regarding the treatment and outcomes and serum estradiol levels were determined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Climara 0.1Mg/24Hr Transdermal System

Drug

Transdermal estradiol patch is used.

Hydrogel patch

Other

Adhesive Hydrogel patch

Primary outcomes

  1. Evidence of disease progression for mild cases

    Time frame: 15 days

    Proportion of patients who are hospitalised in 15 days

  2. Evidence of disease progression for moderate and severe cases

    Time frame: 15 days

    Proportion of patients who required mechanical ventilation or died within 15 days

  3. Kidney function tests

    Time frame: 15 days

    change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application

  4. Platelet

    Time frame: 15 days

    change of platelets in total blood count (*10^3/μL) with estrogen and hydrogel patch application

  5. Markers of coagulation

    Time frame: 15 days

    change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application

  6. Marker of inflammation

    Time frame: 15 days

    change of C-reactive protein (mg/L) levels within 15 days

Secondary outcomes

  1. serum E2 levels

    Time frame: 15 days

    change of serum E2 levels with estrogen and hydrogel patch application

  2. rate of death

    Time frame: 15 days

    comparison of rate of death in each arm

  3. rate of complications

    Time frame: 15 days

    comparison of rate of complications in each arm

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Karakoy Rotary Club
  • Rebul Pharmacy
  • Turkish Menopause and Osteoporosis Society

Registry information

Official study title

Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2023
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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