Is Testosterone for Women FDA Approved? The Honest 2026 Answer

The HRT Index Editorial TeamIndependent women's health research

Published: May 15, 2026Last reviewed: July 2, 2026

Editorial research — not medically reviewed by a clinician. Why this label

By The HRT Index Editorial Team · Independent research — not medically reviewed by a clinician · Educational only, not medical advice · Last verified: July 2026. Some links below are affiliate links; if you start care through one, we may earn a commission at no extra cost to you. It never changes our answer, our verification, or what we tell you to avoid.

Is testosterone for women FDA approved? No.

As of 2026, there is no testosterone product FDA-approved specifically for women in the United States — not a cream, not a patch, not a pill, not a pellet. Testosterone is FDA-approved only for certain uses in men. So “testosterone for women” always means one of two things: a men's approved product used off-label (prescribed for a use it wasn't approved for), or a compounded version (custom-mixed by a pharmacy and not reviewed by the FDA). Neither is FDA-approved for women.

Here's what that actually means for you — because “not approved” is not the same as “not real,” and that gap is exactly where a lot of women get misled.

Quick truth table: what you heard vs. what's real

What you heard	FDA-approved for women?	What it actually means
"Testosterone for women"	No	No U.S. testosterone product is approved specifically for women
"Off-label testosterone"	Product may be approved for men; the use in you is not	A clinician may prescribe it when they judge it appropriate
"Compounded testosterone"	No	Custom-mixed; not reviewed by the FDA for safety, quality, or whether it works
"Testosterone pellets"	No	A fixed dose you can't easily adjust or take back
"Addyi or Vyleesi"	Yes — but they aren't testosterone	FDA-approved non-hormone drugs for low desire, with rules on who can use them

The HRT Index is the independent decision resource for online menopause and HRT care — comparing telehealth providers on clinical legitimacy, care quality, medication fit, price transparency, and access, with every claim verified and dated, so women can choose the path that fits their situation before their first consult.

Best for you / not for you

This page is for you if:

•You heard testosterone might help your libido, energy, or menopause symptoms.
•A doctor told you it’s “not FDA-approved for women” and you want to know what that means.
•You want to understand off-label vs. compounded before you pay for anything.
•You’re comparing online HRT providers and want to avoid slick marketing.

This page isn't enough on its own if:

•You’re pregnant or breastfeeding.
•You have a history of breast, uterine, or other hormone-sensitive cancer.
•You have active liver disease, uncontrolled heart risk, or another condition needing real medical review.
•You want a prescription without a clinician actually evaluating you first.

The right online HRT provider isn't the same for every woman — it depends on your symptoms, your age and whether you have a uterus, your medication route preference, your risk history, your insurance or cash-pay situation, and your state. Some situations belong with an in-person clinician first. Because a general answer can't resolve those for you, use The HRT Index's Find My HRT Path toolto match your situation to the right provider — and to flag when online care isn't the right starting point — before your first consult.

Check your HRT path before you pay → (free, about 90 seconds)

Is testosterone for women FDA approved in the U.S.?

No. There is no testosterone product FDA-approved specifically for women in the United States, and there never has been.The FDA's own testosterone page says these products are approved only for men who have low or no testosterone caused by a medical condition. A women's product exists elsewhere — Australia and New Zealand have an approved testosterone cream for women — but not here.

Let that settle for a second, because it reframes everything. This isn't a case where the “good” approved option exists and shady clinics are pushing a knockoff. For women, in the U.S., there is no approved product to choose. Every legitimate route is off-label or compounded.

Here's the actual, dated history of how we got here:

Where / what	Status	Year
U.S. — any testosterone approved for women	None. Never approved.	—
Australia — AndroFeme 1 cream (1%)	Approved by the TGA for low desire (HSDD) after menopause	2020
New Zealand — AndroFeme 1 cream (1%)	Registered by Medsafe for the same use	April 2025
U.S. — Intrinsa testosterone patch	Reviewers found it effective, but the FDA did not approve it, citing limited long-term safety data and a possible heart-risk concern	2004
Europe — Intrinsa patch	Approved for surgically menopausal women (on estrogen), then pulled from the market	2006, later withdrawn
U.S. — AVA-291 (in development)	Its maker reported the FDA gave development-pathway guidance; early-stage trial planned. This is not approval.	2026

According to a review in The Pharmaceutical Journal, by 2020 there were 31 testosterone products FDA-approved for men — and none for women. Thirty-one to zero. That gap is why so many women feel gaslit when they ask about this. You're not imagining the double standard.

Sources: FDA Testosterone Information; the New Zealand Medsafe AndroFeme 1 data sheet (April 2025) and Australia's TGA registration (2020); The Pharmaceutical Journal's review of testosterone prescribing; Urology Times on the AVA-291 development-pathway guidance.

Wait — if it's not approved for women, how can a doctor prescribe it?

Because “off-label” prescribing is legal and common in medicine. A clinician may prescribe an FDA-approved drug for a use it wasn't approved for when they believe it's medically appropriate. The catch, in the FDA's own words: for that off-label use, the FDA has notdetermined the drug is safe and effective. So it can be reasonable — but it should never be marketed to you as “FDA-approved for women.”

Off-label just means one of these is different from what the FDA reviewed:

•The condition — approved for men's low testosterone, used for a woman's low desire
•The dose — women's doses run far lower than men's
•The route — a cream instead of an injection
•The population — women instead of men

None of that is shady by itself. Doctors prescribe off-label every day — for blood pressure, depression, all kinds of things. What matters is honesty about the label, and a clinician who doses carefully and checks your levels.

Two things to keep in mind. First, testosterone is a Schedule III controlled substancein the U.S. — meaning it's regulated by the DEA, always requires a prescription, and comes with extra rules for prescribing and refills. Anyone offering it without a real prescription is a red flag, full stop.

Second, the FDA actually suggests questions patients should ask about any off-label medicine. We turned those into a checklist — it's further down the page.

FDA-approved vs. off-label vs. compounded testosterone: what's the difference?

These three words get blurred constantly, and the difference decides how much you should trust what you're being sold.FDA-approved means the FDA reviewed that exact product for that exact use. Off-label means a clinician uses an approved product outside its approved label. Compounded means a pharmacy custom-mixes the drug — and the FDA does notreview compounded medicines for safety, effectiveness, or quality before they're sold.

This is our Testosterone FDA Approval & Access Matrix— every option you're likely to run into, its real FDA status, what it means in plain English, and what to check before you pay.

Option you might see	FDA status for women	What it means in plain English	What to verify before paying
A testosterone product made for women	None exists in the U.S.	There is no U.S. testosterone approved specifically for women	If a provider says “FDA-approved testosterone for women,” ask them to name the exact product. They can't — it doesn't exist
A men's FDA-approved product used in a woman	Product approved for men; the use in you is off-label	A clinician may prescribe it at a much lower dose when appropriate	Dose plan, lab monitoring, skin-transfer precautions, what happens if it doesn't help
Compounded testosterone cream / gel	Not FDA-approved	Custom-mixed; not FDA-reviewed for safety, quality, or whether it works	Which pharmacy, the exact dose per press / gram, follow-up labs, how to stop
Testosterone pellets	Not FDA-approved for women	Implanted; hard to adjust once they're in you	Can it be stopped or removed? What if levels go too high?
Addyi (flibanserin)	FDA-approved — not testosterone	A daily pill for low desire in women under 65	Alcohol timing, blood-pressure / fainting warning, 8-week “stop if it's not working” rule
Vyleesi (bremelanotide)	FDA-approved — not testosterone	An as-needed shot for low desire in premenopausal women only	Nausea, heart / blood-pressure cautions, not for postmenopausal women

One phrase to watch: “made with FDA-approved ingredients”

You'll see this on compounding-pharmacy and telehealth pages. It sounds reassuring. It isn't the same thing. A compounded product can be mixed from ingredients that are FDA-approved on their own, and the final custom product is still not FDA-approved— still not reviewed for safety, quality, or whether it works. It can be a real, appropriate option for a specific patient. It's just not FDA-approved. Don't let the wording talk you out of the hard questions.

Check your HRT path before you pay →

Sorts your situation in about 90 seconds and points you to the right next step · Consumer Health Data Privacy Policy

What does testosterone actually do for women — and what won't it do?

The strongest evidence for testosterone in women is for one thing: low sexual desire that causes distress after menopause — known as HSDD (hypoactive sexual desire disorder). For that, testosterone can modestly but meaningfully improve desire, arousal, and satisfaction.

The 2019 Global Consensus Position Statement — endorsed by The Menopause Society, the Endocrine Society, and a long list of other medical groups — reviewed the evidence and drew a hard line: the one evidence-based use is HSDD in postmenopausal women, and the evidence does not back using testosterone for general well-being, energy, mood, memory, bone, heart, or metabolism.

What the evidence supports:

Improving distressing low sexual desire in postmenopausal women, after other causes have been ruled out.

What testosterone should not be sold to you as a fix for:

•Weight loss
•Everyday tiredness or low energy
•Brain fog or memory
•Muscle tone or "optimization"
•Anti-aging or "hormone balancing"
•General mood or well-being

One nuance worth being straight about: the clean evidence lane is postmenopausal. Perimenopause is a grayer area — some clinicians treat late perimenopause off-label, but that's a case-by-case judgment call, not settled evidence.

Low libido usually has more than one cause. Vaginal pain, poor sleep, certain antidepressants, depression or anxiety, stress, thyroid problems, alcohol, and untreated hot flashes can all flatten desire. Testosterone can't out-muscle those. A good clinician looks at the whole picture first — and sometimes the honest answer is “let's fix the sleep and the vaginal dryness before we reach for testosterone.”

Is testosterone safe for women? Side effects, who should avoid it, and monitoring

At low doses that keep you in the normal female range, with regular bloodwork, the short- and medium-term safety picture looks reassuring — and the most common side effects are acne and extra hair growth.The bigger risks come from doses that run too high, and some women shouldn't use it at all. That's exactly why dosing to the normal female range and checking your levels matters.

Common, dose-related side effects

•Acne or oily skin
•Extra facial or body hair
•Body odor changes
•Mild mood shifts

These are tied to dose — they tend to ease when the dose is lowered, which is the whole point of starting low and monitoring.

Effects that can be harder to reverse (from doses that run too high)

•Deepening of the voice
•Enlargement of the clitoris
•Thinning of the scalp hair

These are the ones you really want to avoid — and they're a big reason we're wary of anything that delivers a fixed, unadjustable dose (see pellets, below). Report changes early.

Who should talk to an in-person clinician first

Skip online testosterone as a starting point — and get individual medical advice — if any of these apply:

•Pregnancy or breastfeeding
•A history of breast, uterine, or other hormone-sensitive cancer
•Active liver disease
•Uncontrolled heart or cardiovascular risk
•Uncontrolled high cholesterol
•Severe acne
•A complicated medical history that needs hands-on review

A word on pellets

Testosterone pellets are marketed as convenient — implanted once, then forgotten for months. That “set it and forget it” appeal is also the problem. Once a pellet is in, the dose can't be easily lowered or removed. If your level runs too high, you may be stuck riding it out. Major consensus guidance does not recommend pellets or other forms that push testosterone above the normal female range — and no pellet is FDA-approved for women anyway.

The minimum monitoring bar (before you say yes)

If you and a clinician decide testosterone is worth trying, monitoring isn't optional. Major guidelines point to a pattern like this — use it as a checklist when you vet any provider:

Step	What guidelines point to
Baseline labs	Total testosterone before starting; plus checks like SHBG, cholesterol, and liver function based on your history
First recheck	Around 3–6 weeks, to make sure your level didn’t jump too high
Ongoing	Recheck roughly every 6 months if you continue
Stop rule	If there’s no real improvement by about 6 months, stop — don’t keep raising the dose chasing a vague benefit
Avoid	Pellets and other forms that push levels above the normal female range

Sources: FDA-approved testosterone product labeling; AARP's clinician-sourced guidance on testosterone for women; the 2019 Global Consensus Position Statement; the ISSWSH Clinical Practice Guideline for systemic testosterone in HSDD.

The lower-risk way to actually get testosterone (if it's right for you)

The route that best matches expert guidance is a low, adjustable dose from a licensed clinician who tests your levels, tweaks the dose, and stops treatment if it isn't helping — the opposite of a walk-in clinic that implants a fixed pellet you can't take back. Among the online options we track, Midi runs this kind of monitored, off-label program: real clinician visits, baseline and follow-up labs, a low-dose adjustable cream, and no pellets.

One honest thing before you spend a dollar.

Because there is no FDA-approved testosterone for women, no provider — Midi included — can give you an FDA-approved, insurance-covered testosterone product. It doesn't exist. Midi's testosterone is a compounded cream, and compounded medicine isn't reviewed by the FDA for safety, effectiveness, or quality — Midi states this plainly itself. So if an FDA-approved, insurance-covered medication is your hard line, testosterone isn't your clean path today. Start instead with an estrogen/progesterone menopause HRT conversation, or look at the FDA-approved low-desire options below.

If you're okay with cash-pay, closely monitored, off-label care — the same approach clinicians around the world have used responsibly for decades — Midi skips the insurance maze and gives you the pieces that reduce the biggest avoidable risks: real labs, a low starting dose, and a cream you can adjust or stop anytime. Not a pellet you're stuck with. That's the trade, stated straight.

Here's what we verified about Midi's testosterone program, run through the five pillars of The HRT Index Verification Standard (last checked July 2026):

Pillar	What we verified about Midi's testosterone program (July 2026)
Clinical legitimacy	Licensed clinicians; typically two visits before a testosterone prescription; openly states no FDA-approved female product exists and that its cream is compounded and off-label
Care quality	Treats toward the normal female range; low starting dose; baseline labs, a recheck around 4–6 weeks, then every 6–12 months; won’t do pellets; reviews whether to continue if there’s no benefit within about 8–12 weeks
Medication fit	A compounded testosterone cream applied to the inner thigh. Off-label. Not FDA-approved. No provider can offer an FDA-approved testosterone for women, because none exists
Price transparency	Cream starts at $100 for a 90-day supply (about $33/month); clinician visits are often covered by insurance; labs are billed separately
Access	Testosterone is live in 25 states and expanding: AZ, CA, CO, DC, DE, FL, IA, IL, IN, KS, MA, MD, ME, NC, NJ, NM, NV, NY, OH, OR, PA, TX, UT, VA, WA. (Midi’s broader menopause care is in all 50; testosterone specifically is state-limited — check your state before booking)

Check whether Midi's testosterone program is in your state → Full compounded cream cost guide →

This is off-label, compounded care — start here only if you're comfortable with that.

FDA-approved options for low desire that aren't testosterone

Yes — there are FDA-approved medicines for low sexual desire in women. They just aren't testosterone, and they aren't right for everyone.Two are approved specifically for HSDD: Addyi and Vyleesi. A third, Intrarosa, is FDA-approved but for painful sex, not desire. If the word “FDA-approved” is what you were really chasing, start here.

Addyi (flibanserin)

A daily, non-hormone pill taken at bedtime. Originally approved in 2015 for premenopausal women, its FDA approval was expanded in December 2025 to cover women under 65— so it now includes many postmenopausal women too. It's the only oral FDA-approved option of its kind. It carries a warning about low blood pressure and fainting, especially with alcohol, so you avoid alcohol within about 2 hours of your dose. And there's an 8-week rule: if it isn't helping by then, you stop. See how to get an Addyi prescription online →

Vyleesi (bremelanotide)

An as-needed shot you give yourself about 45 minutes before sex. FDA-approved in 2019 — but for premenopausal women only(not postmenopausal women, not men). Nausea is common, and it isn't for women with uncontrolled high blood pressure or known heart disease. Not testosterone.

Intrarosa (prasterone)

A vaginal insert made from DHEA (a hormone your body converts). It's FDA-approved for painful sex due to menopause— a tissue-and-dryness problem — not for low desire, and it's not testosterone replacement. If your main issue is pain or dryness rather than lost desire, this is a very different (and approved) conversation to have with your clinician.

Sources: FDA / DailyMed prescribing information for Addyi and Vyleesi; Urology Times and Contemporary OB/GYN on the December 2025 Addyi expansion; DailyMed and AARP on prasterone / Intrarosa.

What does testosterone for women cost? Will insurance cover it?

Plan to pay cash for the medication.Because there's no FDA-approved product for women, insurance rarely covers testosterone for women — and the coupons and generics that exist are for men's products. Compounded testosterone cream generally runs about $30–$80 a month; Midi's cream starts at $100 for a 90-day supply, with clinician visits often covered by insurance and labs billed separately.

What you're paying for	Typical cost	Covered by insurance?
Compounded testosterone cream (general market)	~$30–$80/month	Rarely — no FDA-approved product means no clean coverage pathway
Midi testosterone cream	Starts at $100 / 90-day supply (~$33/mo)	Cream: cash-pay. Visits: often covered
Clinician visits	Varies; Midi bills insurance for visits	Often, yes
Baseline + follow-up labs	Varies by panel and insurer	Sometimes
Testosterone pellets	Higher, and hard to adjust — we don’t recommend them as a default	No

Watch for the trap of a headline price that only covers the visit, leaving the medication, labs, and shipping to pile on later. Ask for the all-in first-90-day cost before you commit.

See Midi's current testosterone pricing → Full insurance guide for testosterone →Get your personalized HRT path first →

Which online providers actually prescribe testosterone to women?

Some online providers prescribe testosterone to women; most don't. It depends on the provider, your state, the medication route, and the clinician's judgment. Here's the current posture of the providers we track, verified from their own public pages as of July 2026. Notice how few actually offer it.

Provider	Current testosterone posture (verified July 2026)	How to think about it
Midi Health	Offers clinician-guided, monitored testosterone (a compounded cream); no pellets; state-limited; discloses it's compounded and not FDA-approved	The clearest monitored pathway we found — for readers who understand it's off-label / compounded and want oversight
Winona	Does not prescribe testosterone. Offers estradiol, estriol, progesterone, and a DHEA supplement	A fit for estrogen / progesterone menopause care — not a testosterone route. DHEA is a precursor, not testosterone
Inner Balance (Oestra)	Contains estradiol and progesterone and does not include testosterone	Consider only as a separate estrogen / progesterone conversation — not a testosterone option
Sesame	Its own policy says its online providers do not prescribe controlled substances via telehealth — and it lists testosterone by name	Not a testosterone route through telehealth. In-person Sesame providers may evaluate controlled-substance prescriptions when appropriate
Hers	Its perimenopause page lists estradiol pills or patches, estradiol vaginal cream, and oral progesterone. Testosterone is not listed	Not a testosterone route today; confirm directly before assuming otherwise

Why we won't crown a “best FDA-approved testosterone provider for women”

Because there's no such thing — and any page claiming otherwise is either careless or selling you something. No U.S. testosterone product is FDA-approved specifically for women, so no provider can offer one. What a good provider canoffer is honest labeling, careful dosing, and real monitoring. That's the bar. Anyone marketing “FDA-approved testosterone for women” has already failed it.

Is testosterone right for you? A simple way to tell

Testosterone is most appropriate for postmenopausal women with distressing low desire that isn't explained by other causes — after those other causes are addressed.It's not the tool for energy, weight, or mood, and it's not for women with a history of hormone-sensitive cancer. For a lot of women, the honest answer is “not yet,” or “not this — something else fits better.”

Your main issue is distressing low desire, and you’re past menopause: This is the one situation with real evidence behind testosterone. Worth a careful, monitored conversation with a clinician.

You’re in perimenopause with lots of symptoms (hot flashes, sleep, mood): Estrogen/progesterone therapy usually comes first. Find the right starting point rather than jumping to testosterone.

Your main issue is painful sex or dryness: That’s a tissue problem — local vaginal therapy (including FDA-approved options) usually fits better than testosterone.

You want testosterone for energy, weight, or brain fog: The evidence doesn’t support that. Don’t spend money chasing it here.

You have a hormone-sensitive cancer history, liver disease, or you’re pregnant/breastfeeding: This needs an in-person clinician, not an online start.

The questions to ask before you pay (no strings — take these with you)

The FDA suggests patients ask specific questions about any off-label medicine. We turned that into a simple checklist. Screenshot it, or bring it to your consult:

7 Questions to Ask Before You Pay for Testosterone

Is this FDA-approved for women? (The honest answer is no — see who says otherwise.)
Is what you're prescribing off-label, or compounded?
Exactly what symptom are we treating?
What evidence supports it for that symptom?
What dose and route, and how will you keep me in the normal range?
What labs and follow-up will you order, and how often?
What happens if I get side effects — or if it doesn't work?

If a provider dodges these, that's your answer.

Take the free Find My HRT Path assessment →

About 90 seconds. It'll also flag when you should see someone in person first.

Will there ever be an FDA-approved testosterone for women?

Maybe — but not soon.In January 2026, the company Aviva Bio reported that the FDA gave it guidance on a development pathway for a women's-specific testosterone therapy (called AVA-291), with an early-stage trial planned for 2026. That's a real step, but it is not approval, and AVA-291 is not something you can get today. Until an approval actually happens, every testosterone option for women in the U.S. stays off-label or compounded.

We re-check this every quarter. If it changes, this page changes — and the “Last verified” date at the top tells you when we last looked.

How we verified this

We didn't rank providers by payout or treat testosterone as a simple yes/no product. We read the FDA's status directly, traced the international history, checked the major medical-society positions, confirmed the FDA-approved non-testosterone options, and verified each provider's current testosterone posture from their own public pages — keeping FDA-approved, off-label, and compounded strictly separate the whole way.

The FDA's testosterone approval status (no product approved for women)
What "off-label" means, in the FDA's own words
The FDA's stance that compounded drugs aren't reviewed for safety, quality, or effectiveness
That testosterone is a Schedule III controlled substance (DEA)
The 2019 Global Consensus Position Statement (postmenopausal HSDD supported; compounded advised against; other uses not supported)
The FDA-approved non-testosterone options — Addyi (expanded to women under 65 in December 2025), Vyleesi (premenopausal only), Intrarosa (painful sex)
Midi's public testosterone page (compounded cream, monitored, no pellets, 25 states)
Winona's HRT FAQ (does not prescribe testosterone)
Inner Balance/Oestra's pages (estradiol + progesterone, no testosterone)
Sesame's policy (no controlled substances via telehealth; testosterone named)
Hers' perimenopause page (estradiol and progesterone; no testosterone)
The international picture: Australia's AndroFeme (2020), New Zealand's AndroFeme (April 2025), the U.S. Intrinsa non-approval (2004), and AVA-291 in development (2026)

We're an independent editorial team, not a clinic. This page is research to help you make a good next decision — it is not a diagnosis or a prescription, and it isn't medically reviewed by a clinician.

Bottom line: what should you do next?

If your only question was FDA approval, the answer is no.

Testosterone is not FDA-approved specifically for women in the U.S., and anyone telling you otherwise is misleading you. If you're still weighing care, the next move isn't to chase a product. It's to figure out whether your symptoms point to FDA-approved menopause hormone therapy, local vaginal treatment, an FDA-approved low-desire medicine, a monitored off-label testosterone conversation, or an in-person visit first.

That's exactly what our free tool is built to do — sort your situation and hand you a clear next step, including when not to start online.

Take Find My HRT Path → (about 90 seconds)See if Midi is in your state →

Consumer Health Data Privacy Policy

Educational only — not medical advice. This page is updated quarterly; the “Last verified” date at the top reflects when we last checked each claim. FDA-approved and compounded / off-label options are labeled separately throughout; compounded or off-label is never implied to be equivalent to, safer than, or more natural than FDA-approved medication.

Frequently asked questions

Is testosterone for women FDA approved?▼

No. There is no testosterone product FDA-approved specifically for women in the United States. FDA-approved testosterone products are approved only for certain uses in men.

Is testosterone cream FDA-approved for women?▼

No U.S. testosterone cream is FDA-approved specifically for women. A cream may be compounded (custom-mixed) or adapted off-label from another product, but that is not the same as FDA approval for women.

Is compounded testosterone FDA-approved?▼

No. The FDA does not approve compounded drugs and does not review them for safety, effectiveness, or quality before they are sold. Compounded testosterone can be appropriate for a specific patient, but it is not FDA-approved.

Can doctors legally prescribe testosterone to women?▼

Yes. A clinician may prescribe an FDA-approved drug for an off-label use when they judge it medically appropriate. The FDA notes it has not determined the drug is safe and effective for that off-label use, so it should not be marketed as "FDA-approved for women."

What is testosterone used for in women?▼

The most evidence-supported use is carefully selected, monitored treatment of distressing low sexual desire (HSDD) in postmenopausal women. Guidelines do not support using it for energy, weight loss, mood, memory, or general well-being.

Is testosterone a controlled substance?▼

Yes. Testosterone is a Schedule III controlled substance in the U.S., so it always requires a prescription and follows extra prescribing and refill rules.

Are testosterone pellets FDA-approved for women?▼

No. No testosterone pellet is FDA-approved for women, and pellets deserve extra caution because the dose cannot be easily adjusted or removed once implanted.

Does insurance cover testosterone for women?▼

Usually no. Because there is no FDA-approved testosterone product for women, insurance rarely covers the medication and most women pay cash. Office visits and labs may be covered depending on your plan and provider.

Does Winona prescribe testosterone?▼

No. Winona's public FAQ says it prescribes estradiol, estriol, progesterone, and a DHEA supplement, and that it currently does not prescribe testosterone.

Does Midi prescribe testosterone?▼

Yes, as a monitored off-label program. Midi offers clinician-guided testosterone care (a compounded cream), does not use pellets, monitors labs, and is limited by state. Midi discloses that compounded testosterone is not FDA-approved.

Are Addyi and Vyleesi testosterone?▼

No. They are FDA-approved non-hormone medicines for low sexual desire. Addyi is approved for women under 65; Vyleesi is approved for premenopausal women only. Both have specific rules and warnings.

Sources

U.S. Food and Drug Administration — Testosterone Information. fda.gov
U.S. Food and Drug Administration — Understanding Unapproved Use of Approved Drugs “Off Label.” fda.gov
U.S. Food and Drug Administration — Human Drug Compounding. fda.gov
Davis SR, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women (2019), Journal of Clinical Endocrinology & Metabolism.
ISSWSH — Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women (2021). PMC.
The Menopause Society — Practice resources on testosterone for HSDD. menopause.org
Medsafe (New Zealand) — AndroFeme 1 Data Sheet (April 2025). medsafe.govt.nz
The Pharmaceutical Journal — Testosterone in menopause: a review of the evidence and prescribing practice.
Urology Times — FDA provides guidance on development pathway for testosterone therapy for women (AVA-291).
Urology Times — FDA approves flibanserin for HSDD in postmenopausal women (December 2025).
DailyMed — Addyi (flibanserin) prescribing information.
DailyMed — Vyleesi (bremelanotide) prescribing information.
DailyMed — Intrarosa (prasterone) prescribing information.
AARP — Do Older Women Need to Take Testosterone? aarp.org
DEA Diversion Control Division — Controlled Substance Schedules. deadiversion.usdoj.gov
Midi Health — Testosterone for women. joinmidi.com (verified July 2026)
Winona — Hormone Therapy for Menopause. bywinona.com (verified July 2026)
Sesame — Controlled substances policy. sesamecare.com (verified July 2026)
Hers — Perimenopause care. forhers.com (verified July 2026)