Menopause Treatments That Are FDA-Approved—And Those That Aren’t
Menopause isn’t a disease—it’s a natural life transition. But that doesn’t mean the symptoms don’t deserve treatment. From hot flashes and night sweats to sleep disruption and mood changes, many women seek relief. But what’s actually approved and effective? And what’s marketing hype?
Let’s break down what’s FDA-approved, what’s supported by major medical societies like the North American Menopause Society (NAMS) and the Endocrine Society, and what to avoid—especially when it comes to peptides, collagen, and testosterone.
✅ FDA-Approved Menopause Treatments
1. Estrogen & Progesterone (Hormone Therapy)
Hormone therapy is the first-line treatment for vasomotor symptoms (hot flashes, night sweats), vaginal dryness, and even osteoporosis prevention in postmenopausal women.
Estrogen (oral, transdermal, or vaginal) and micronized progesterone (for those with a uterus) are FDA-approved.
These treatments are endorsed by NAMS, the Endocrine Society, and the International Menopause Society when prescribed appropriately for symptom management.
📚 Evidence:
North American Menopause Society. (2022). Nonhormonal Management of Menopause-Associated Vasomotor Symptoms: 2022 Position Statement. Menopause, 29(11): 1237-1253.
Stuenkel, C.A. et al. (2015). Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, 100(11): 3975–4011.
2. Non-Hormonal FDA-Approved Medications
Some women can't or don’t want to use hormone therapy. Thankfully, non-hormonal options have emerged:
Fezolinetant (Veozah) – FDA-approved in 2023, this neurokinin-3 (NK3) receptor antagonist targets hot flashes by regulating brain thermoregulation centers. It’s the first non-hormonal option of its kind.
Brisdelle (low-dose paroxetine) – A selective serotonin reuptake inhibitor (SSRI), approved for moderate to severe vasomotor symptoms.
📚 Evidence:
FDA Drug Approval Report (2023): Veozah (Fezolinetant) [FDA.gov]
Joffe, H. et al. (2014). Low-Dose Paroxetine for Menopausal Hot Flashes. JAMA Intern Med, 174(3): 460–468.
Not FDA-Approved for Menopause
1. Peptides (e.g. BPC-157, CJC-1295, Ipamorelin)
Peptides have been marketed for energy, muscle tone, and "anti-aging," but they are not approved by the FDA for any menopausal symptom relief. In fact, the FDA has actively banned several of these from compounding pharmacies due to safety concerns and lack of efficacy.
📚 Evidence:
FDA Compounding Risk Alert (2022) – List of Banned Bulk Drug Substances [FDA.gov]
Hone Health. (2023). FDA Bans Peptides. [honehealth.com]
2. Collagen Supplements
Collagen is sold as a beauty or joint support supplement—but it is not approved or regulated to treat any menopause-related conditions. Some research suggests minor benefits for skin elasticity and bone density, but evidence is inconsistent and not recognized by medical societies as treatment.
📚 Evidence:
Zdzieblik, D. et al. (2017). Collagen Supplementation Improves Bone Mineral Density in Postmenopausal Women. Nutrients, 9(1): 20.
Cleveland Clinic. (2021). What to Know About Collagen Supplements. [my.clevelandclinic.org]
Why Testosterone is NOT Approved for Menopause
❌ Not FDA-Approved for General Menopausal Symptoms
Testosterone is not FDA-approved for use in women to treat fatigue, low mood, brain fog, weight gain, or general "hormone balance" issues during menopause.
The only context where testosterone might be prescribed is Hypoactive Sexual Desire Disorder (HSDD)—a condition defined by persistently low sexual desire that causes distress and has no other explanation.
Even in this case:
It must be prescribed off-label
Doses must be very low
No testosterone product for women is approved in the U.S.—only in Australia and the UK.
📚 Evidence:
Davis, S.R. et al. (2019). Global Consensus Position Statement on the Use of Testosterone Therapy for Women. Climacteric, 22(4): 429–435.
Endocrine Society Guidelines (2014): “Testosterone therapy should not be used in women without a diagnosis of HSDD.”
FDA Drug Safety Communication. (2020). “Testosterone not approved for use in women.”
Risks of Using Testosterone Without HSDD Diagnosis
Using testosterone without HSDD or outside of medical guidance can result in:
Virilization: acne, facial hair, deep voice, clitoral enlargement
Lipid profile disruption, liver stress, and possible cardiovascular risk
Mood instability and aggression
Hormonal imbalance and estrogen suppression
No long-term safety data for use in women
Many clinics promote pellets or compounded testosterone with little oversight. These versions are not regulated, not properly dosed for female physiology, and pose serious health risks.
📚 Evidence:
Wierman, M.E. et al. (2014). Androgen Therapy in Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, 99(10): 3489–3510.
North American Menopause Society. (2022). Hormone Therapy Position Statement.
Takeaway from Elle Jolie Wellness
At Elle Jolie Wellness, we believe in evidence-based care, not TikTok trends or influencer hype.
✅ FDA-approved HRT, non-hormonal medications, and lifestyle changes (like resistance training and nutritional support) are the gold standards.
❌ Peptides, collagen supplements, and testosterone pellets are not safe substitutes and should never be sold as such.
If you’re navigating menopause, don’t do it alone. Work with accredited professionals who know the science and support your body’s true needs.