The Informed Consent, Female Testosterone and/or Estradiol Pellet Insertion form documents a patient's understanding and agreement before a clinician implants subcutaneous hormone pellets. Medical spas, wellness clinics, and hormone therapy providers use it to explain the procedure, risks, alternatives, and off-label status so patients can make an informed decision. This template is a starting point, so confirm the final wording with your own compliance or legal counsel.
What does an Informed Consent, Female Testosterone and/or Estradiol Pellet Insertion include?
Most female pellet consent forms combine a plain-language description of the procedure with disclosure of risks, benefits, and alternatives. Common sections include:
- Patient identification. Captures the patient's name, date of birth, and the date of the planned insertion.
- Procedure description. Explains how testosterone and/or estradiol pellets are placed under the skin, usually in the upper buttock, and how they release hormones over time.
- Expected benefits. Outlines the symptoms the therapy aims to address while noting that individual results are not guaranteed.
- Risks and side effects. Lists possible reactions such as bruising, infection, pellet extrusion, bleeding, hair growth, acne, mood changes, and cardiovascular considerations.
- FDA and off-label disclosure. States that compounded hormone pellets are not FDA approved and that this use may be considered off-label.
- Alternatives to treatment. Describes other options such as oral, patch, cream, or injectable hormones, and the choice to decline treatment.
- Acknowledgment and questions. Confirms the patient had the chance to ask questions and understands the information provided.
- Signatures. Collects the patient signature, date, and the clinician or witness signature confirming the consent discussion.
How to administer the Informed Consent, Female Testosterone and/or Estradiol Pellet Insertion
- Send the consent to the patient by text or email once the pellet procedure is scheduled.
- Ask the patient to read each risk and disclosure section carefully before signing.
- Have the clinician review questions and confirm the consent discussion in person.
- Collect the patient e-signature and the provider or witness signature at check-in.
- Store the signed consent securely so it is ready before the visit and easy to retrieve.
- Send a fresh consent for each new pellet insertion cycle for returning patients.
Who uses the Informed Consent, Female Testosterone and/or Estradiol Pellet Insertion?
- Medical spas offering hormone optimization and wellness services.
- Hormone therapy and anti-aging clinics that manage pellet insertion programs for women.
- Gynecology and women's health practices treating menopausal and perimenopausal symptoms.
- Functional and integrative medicine providers who prescribe compounded hormone therapy.
Digital vs paper Informed Consent, Female Testosterone and/or Estradiol Pellet Insertion
| Paper | Zentake digital |
|---|---|
| Handwriting can be hard to read | Typed entries are clear and complete |
| Filled out in the waiting room | Completed before the visit from any device |
| Ink signature on a printed page | Legally valid e-signature captured online |
| Stored in a filing cabinet | Encrypted, HIPAA-compliant storage |
| Reprinted for each new cycle | Resent in seconds for returning patients |
| Staff scan and file by hand | Signed forms organized automatically |
How Zentake helps with the Informed Consent, Female Testosterone and/or Estradiol Pellet Insertion
- E-signatures. Capture legally valid signatures from the patient and provider on every consent.
- Custom form builder. Adapt the consent wording to match your protocols and state requirements.
- Before the visit. Help medical spa practices collect signed consent before patients arrive.
- In-clinic tablets. Let patients finish the consent on a tablet if they did not complete it beforehand.
- HIPAA compliant. Every plan includes encrypted storage and a signed BAA to protect patient information.
References
The U.S. Food and Drug Administration notes that compounded hormone products, including pellets, are not FDA approved and have not been evaluated for safety or effectiveness. Consent forms should reflect this off-label status. See the FDA guidance on drug compounding.
Professional guidance such as the American College of Obstetricians and Gynecologists opinion on compounded bioidentical hormone therapy stresses documented informed consent. Requirements vary by state and practice, so confirm your wording with your own compliance or legal counsel.
Last updated: August 2026