None listed
Conditions
Brief summary
This research study is looking at understanding how estrogen blockade in women, with either estrogen antagonist or aromatase inhibitor drugs, influence circulating levels of testosterone or pro-androgens (precursor steroids that can be converted to testosterone). The aim of the study is to investigate serum and urine androgen profiles in healthy women undertaking typical 5-day treatments with estrogen blockade using an anti-estrogen (Clomifene) or an aromatase inhibitor (letrozole) compared to a placebo (a treatment with no active medicine).
Interventions
5 days of estrogen blockade therapy with either Clomifene or Letrozole.
Clomifene 50mg oral tablet. 1 tablet daily for 5 days.
Patients will be given 5 tablets on day 1 of the study. Patients will be asked about compliance to treatment on day 5 and they will return the drug bottle to the investigators. Drug levels will be checked on day 5 blood samples to confirm compliance.
Letrozole 5mg oral tablet. 1 tablet daily for 5 days
Patients will be given 5 tablets on day 1 of the study. Patients
5 days of estrogen blockade therapy with either Clomifene or Letrozole. Clomifene 50mg oral tablet. 1 tablet daily for 5 days. Patients will be given 5 tablets on day 1 of the study. Patients will be asked about compliance to treatment on day 5 and they will return the drug bottle to the investigators. Drug levels will be checked on day 5 blood samples to confirm compliance. Letrozole 5mg oral tablet. 1 tablet daily for 5 days Patients will be given 5 tablets on day 1 of the study. Patients will be asked about compliance to treatment on day 5 and they will return the drug bottle to the investigators. Drug levels will be checked on day 5 blood samples to confirm compliance.
Sponsors
Concord Hospital Andrology Department
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy female, aged 18-40 years • Regularly exercising (at least 2-3 times weekly) • Reliable contraception (e.g., oral contraceptives containing ethinyl estradiol but not estradiol, medicated or plain intrauterine device (IUD), tubal ligation, vasectomized or no male partner)
Exclusion criteria
• Not using any systemic products containing estradiol or testosterone • No chronic illness or regular prescribed medication likely to interfere with steroid metabolism • Not involved in competitions compliant with the World Anti-Doping Agency (WADA) regulations
Outcome results
None listed