Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT04853069
Eligibility Criteria:
Inclusion Criteria:
* Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)
* Adult males \> 18 years of age OR
* Post-menopausal women (spontaneous amenorrhoea for \>12 months in the absence of any other cause)
Exclusion Criteria:
Women:
* taking oestrogen supplements or oestrogen receptor antagonists
* with abnormal genital bleeding
* with a history of breast cancer
* with a history of endometrial or ovarian cancer
* with untreated endometrial hyperplasia
Men:
• taking hormone therapies (e.g. for prostate cancer)
Any subject:
* failure to obtain consent
* taking lamotrigine
* with a thromboembolic disorder (e.g. Protein C or Protein S deficiency, antithrombin III deficiency)
* with pre-existing liver or renal disease
* with known allergy to exogenous oestrogens
* with a history of porphyria
* with a history of thromboembolic event including deep vein thrombosis, thromboembolic stroke or pulmonary emboli
* taking part in another interventional clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04853069
Study Brief:
Protocol Section:
NCT04853069