Important points to note:
Spakinect completes GFEs for Hormone Replacement Therapy (HRT) for:
Estrogen, Progesterone, and Testosterone
Testosterone only
At this time, our providers do not prescribe any medications. The prescription, administration instructions, dose, frequency and route will need to come from the clinic’s medical director/prescriber.
Clients must establish protocols through their medical director for HRT therapy. The clinic’s SOPs should clearly define all screening, dosing, and monitoring requirements. Spakinect recommends that the patient be monitored throughout the entire treatment.
What is Hormone Replacement Therapy (HRT)?
Hormone Replacement Therapy is used to supplement hormones such as Estrogen, Progesterone, or Testosterone in individuals with low or deficient levels. HRT is indicated for males and females with conditions associated with a deficiency or absence of endogenous hormones.These treatments are commonly used to manage symptoms related to menopause, andropause, or hormone deficiencies.
What hormones are included in HRT GFEs?
Our providers currently complete GFEs for Estrogen, Progesterone, and Testosterone and/or Testosterone only.
Do you review labs or require labs for HRT?
Currently, our providers do not review labs, but they will take into consideration any reported lab abnormalities during the medical history review. All required lab monitoring should be directed by your medical director and established within your clinic’s SOPs.
How is monitoring handled for HRT patients?
Spakinect’s treatment plans recommend monitoring patients with thyroid or prostate conditions or other relevant comorbidities. Patients should be counseled on boxed warnings and medication interactions related to HRT. Monitoring may include hormone level labs, thyroid function (if applicable), PSA testing for males, lipid and hematocrit levels (for testosterone), and assessment for adverse effects such as fluid retention, abnormal bleeding, or vision changes. Additional screenings and follow-up are determined by the clinic's medical director.
What does the HRT screening process involve?
Thorough review of medical history, medications, allergies, recent surgeries or procedures, and permanent implants
Inquiry about relevant conditions such as thyroid disorders, cardiovascular risk factors, prostate history, or hormone-sensitive cancers
Follow-up questions tailored to each patient’s unique health status
Our process is guided by product inserts, clinical manuals, and evidence-based practices.
How long is the HRT GFE good for?
HRT GFE approvals are valid for 12 months from the documented timestamp. If a patient’s medical status changes within this period, the GFE becomes null and void, and a new GFE must be completed prior to further administration of HRT.
Can Spakinect provide dosing or prescribing guidance?
All medication dosing, frequency, route of administration, and monitoring requirements must be outlined by your onsite medical director in your clinic’s protocols and SOPs.
What about compounded hormones or bioidentical hormone therapy?
At this time, Spakinect evaluates Estrogen, Progesterone, and Testosterone therapies only. If your clinic utilizes compounded or bioidentical hormone therapy, your MD must establish these protocols independently, as Spakinect does not validate compounded substances.
What additional considerations should we include in our clinic’s SOPs?
Initial and ongoing monitoring parameters (labs, vitals, and symptom tracking)
Counseling patients on boxed warnings, side effects, and interactions
Frequency of follow-up visits
Criteria for discontinuation or referral to a specialist
Any other questions regarding HRT or our GFEs?
Please email clinicalsupport@spakinect.com for any additional questions.