Compounded medication — not FDA-approved
This article discusses compounded medications that are not FDA-approved products. Compounded medications are prepared by licensed 503A/503B pharmacies based on a licensed provider's prescription. They are not evaluated by the FDA for safety or efficacy. Nothing in this article constitutes medical advice, diagnosis, or a recommendation to use any product. All prescribing and dosing decisions are made by a licensed physician during intake.
In this article
- 01why three bodies, three perspectives
- 02menopausal hormone therapy: the central recommendation
- 03progesterone in women with a uterus
- 04testosterone for women: where the bodies differ most
- 05comparison table: key questions, three bodies
- 06where the bodies are more cautious than some clinical practice
- 07how clinicians actually use these guidelines
- 08footnotes
why three bodies, three perspectives
Women's hormone therapy in the US is addressed by multiple credentialing and guideline-issuing organizations. Three of the most influential:
ISSWSH — the International Society for the Study of Women's Sexual Health. A sexual medicine specialty body that focuses on female sexual dysfunction, including HSDD, and has led the field in producing consensus documents on testosterone therapy for women.
NAMS / The Menopause Society — the specialty body for menopause medicine. Publishes position statements on hormone therapy, bioidentical hormones, and symptom management. Credentials clinicians as Menopause Society Certified Practitioners (MSCP).
The Endocrine Society — the broader endocrinology specialty society. Publishes Clinical Practice Guidelines across the full scope of endocrine disorders, including androgen therapy in women and menopausal hormone therapy.
Each body has a somewhat different scope, evidence standard, and stylistic approach. They generally align on the central empirical questions but differ on some emphases — which interventions to recommend, which populations to prioritize, and how cautiously to frame newer evidence.
This article summarizes where the three bodies agree, where they differ, and how each frames the published evidence. It's not a substitute for reading the primary documents — and it isn't a personalized clinical recommendation. Decisions for any individual patient are made between that patient and a prescribing physician.
menopausal hormone therapy: the central recommendation
All three bodies have issued substantive position statements on menopausal hormone therapy (HT) in recent years. The main recommendations have moved much closer together since researchers re-analyzed the Women's Health Initiative data and the ELITE trial published.
The Menopause Society (NAMS) 2022 Hormone Therapy Position Statement is the most comprehensive current document specifically on menopause hormone therapy. It endorses hormone therapy as effective treatment for vasomotor symptoms (hot flashes and night sweats), the genitourinary syndrome of menopause (vaginal dryness, urinary issues, discomfort after estrogen drops), and supports its use for bone-loss prevention in appropriate candidates. The statement emphasizes individualization — based on timing of initiation, duration, patient age and health status, route of administration, and dosing.[1]
The Endocrine Society's 2015 Clinical Practice Guideline on Treatment of Symptoms of the Menopause (Stuenkel et al.) aligns broadly with NAMS on the core question. It emphasizes the timing hypothesis — that initiation within 10 years of menopause onset or before age 60 has a more favorable risk-benefit profile than later initiation.[2]
ISSWSH focuses more narrowly on sexual health and generally supports the use of local estrogen and other interventions for genitourinary symptoms.
All three bodies endorse local vaginal estrogen for the genitourinary syndrome of menopause, noting that the systemic absorption of appropriately dosed vaginal estrogen is minimal and the risk-benefit profile is favorable even in women who aren't candidates for systemic hormone therapy.
Specific dose ranges are discussed in the source documents and determined by prescribing physicians based on individual patient factors. Guideline bodies describe the evidence base, not universal doses.
progesterone in women with a uterus
All three bodies agree on the need for progestogen co-administration in women with an intact uterus who are receiving systemic estrogen, to reduce the risk of endometrial hyperplasia and carcinoma. This is one of the least-contested points across the guidelines.
Where the bodies differ is in framing of progesterone forms:
Micronized progesterone vs synthetic progestins. NAMS and the Endocrine Society both acknowledge that the published evidence (notably the French E3N cohort) suggests micronized progesterone may have a more favorable profile than some synthetic progestins for breast and cardiovascular outcomes, though the evidence is primarily observational. Both bodies consider both classes acceptable within current practice, with clinical judgment individualizing the choice.
Compounded bioidentical progesterone. NAMS has been more cautious than some functional medicine clinicians on compounded bioidentical hormones, noting that FDA-approved micronized progesterone products are available (Prometrium and generic equivalents) and that compounded preparations lack the standardization of approved products. Functional medicine clinicians who prescribe compounded progesterone note that the FDA-approved product is itself micronized progesterone, and that the clinical distinction is largely about formulation rather than molecule. Both views appear in the literature.
The practical picture: a woman with a uterus taking systemic estrogen needs progestogen co-administration. Which progestogen — bioidentical or synthetic, FDA-approved or compounded — is something patient and physician work out together.
testosterone for women: where the bodies differ most
Testosterone therapy for women is the category where the three bodies have historically differed most, and where guidance has evolved substantially.
ISSWSH. The most prescriber-friendly position. The 2019 Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Davis et al.) is the strongest and most detailed endorsement across the three bodies. It supports testosterone therapy for postmenopausal women with HSDD, with doses targeting the premenopausal physiological range, and with appropriate monitoring of total testosterone and SHBG.[1] ISSWSH has historically been the most active in championing this intervention.
The Endocrine Society. The 2014 Clinical Practice Guideline (Wierman et al.) is more cautious than ISSWSH. It acknowledges the evidence for testosterone in postmenopausal HSDD but phrases the recommendation more conservatively, emphasizes the lack of FDA-approved products, and is skeptical of testosterone therapy for non-sexual indications (bone, cardiovascular, general wellbeing).[2] The Endocrine Society has said in later statements that they're working on an updated guideline that reflects the newer evidence.
The Menopause Society (NAMS). Historically more cautious than ISSWSH; has evolved toward more supportive framing in recent position statements. NAMS acknowledges the evidence for testosterone in postmenopausal HSDD and supports its use in appropriate patients, while continuing to emphasize the absence of an FDA-approved female product as a structural consideration. NAMS position documents generally align with the ISSWSH recommendation on the central question.
The three bodies are closer together now than a decade ago. All endorse, at some level of conviction, testosterone therapy for postmenopausal HSDD. All note the absence of an FDA-approved US product. All emphasize individualized prescribing by experienced clinicians with appropriate monitoring. See the US prescribing landscape for female testosterone for the regulatory history.
comparison table: key questions, three bodies
The major questions summarized across the three bodies:
| Question | ISSWSH | NAMS / Menopause Society | Endocrine Society |
|---|---|---|---|
| HT for vasomotor symptoms | Supports | Supports (central to 2022 position) | Supports (2015 CPG) |
| Local vaginal estrogen for GSM | Supports | Supports | Supports |
| Timing hypothesis (init within 10 yrs of menopause) | Aligned | Central to position | Central to 2015 CPG |
| Micronized progesterone vs synthetic progestins | Not primary focus | Acknowledges evidence favoring micronized; accepts both | Similar, nuanced |
| Compounded bioidentical hormones | Not primary focus | Cautious; prefers approved products where available | Cautious; prefers approved products |
| Testosterone for postmenopausal HSDD | Supports (2019 Global Consensus — strongest endorsement) | Supports | Supports with more conservative phrasing (2014 CPG) |
| Testosterone for non-sexual indications | Evidence not sufficient | Evidence not sufficient | Evidence not sufficient |
| Testosterone in premenopausal women | Evidence not sufficient | Evidence not sufficient | Evidence not sufficient |
| DHEA | Variable endorsement | Vaginal DHEA supported (FDA-approved prasterone); systemic evidence mixed | Evidence for systemic DHEA mixed |
The pattern: substantial convergence on the core recommendations, differences primarily in framing and specialty-specific emphasis.
Key Takeaway
where the bodies are more cautious than some clinical practice
It's worth naming where guideline-level recommendations lag behind some clinical practice, because the gap shapes how contemporary clinicians talk about hormone therapy.
Compounded bioidentical hormones. All three bodies prefer FDA-approved products where available and express caution about the compounding category. In actual clinical practice, many menopause specialists and essentially all women's hormone optimization practices prescribe compounded preparations routinely, citing individualization of dose and formulation. The guideline bodies' caution isn't a prohibition — 503A compounded prescribing is legal and legitimate when done appropriately — but the bodies generally recommend approved products as first-line where they meet the clinical need.
Testosterone for non-sexual indications. All three bodies agree that evidence for testosterone in women for bone, cardiovascular, body composition, or general wellbeing indications is insufficient to support routine prescribing for those reasons. Some clinicians in women's hormone optimization practice do prescribe testosterone for a broader indication set. This is a real gap between guideline and some clinical practice.
Oxytocin and compounded topical arousal preparations. None of the three bodies has a formal position on these. Both categories are used in clinical practice by subsets of clinicians (particularly in sexual medicine and women's hormone optimization) drawing on the broader research literature and compounding authority.
Peptide therapy. Not a core subject of women's hormone guidelines. Clinicians in this space draw on the broader peptide and endocrine literature rather than women's hormone guideline documents.
A useful frame: the guideline bodies are stating where the evidence base is strongest and where the field has reached consensus. They're not stating the outer limit of what a careful doctor can legitimately prescribe. The two are related but distinct.
how clinicians actually use these guidelines
In practice, physicians prescribing women's hormone therapy use guideline documents in several ways:
As a reference for the evidence base. The documents summarize and cite the primary literature more comprehensively than any individual can. When a clinical question arises, reading the relevant guideline is faster than assembling the literature from scratch.
As a frame for patient conversations. The guidelines establish what counts as mainstream practice and what counts as more individualized. A physician can tell a patient that testosterone for postmenopausal HSDD has guideline-level support across ISSWSH, NAMS, and the Endocrine Society — and that the same guidelines don't yet support testosterone for premenopausal wellbeing indications. Being honest about the guideline picture is part of informed consent.
As a baseline, not a ceiling. Individualized clinical practice regularly incorporates interventions that are within legitimate physician judgment but outside what current guidelines specifically recommend. Off-label use of FDA-approved medications and 503A compounded preparations are legal and appropriate when the physician has good clinical grounding. Physicians vary in how far they operate from the guideline baseline — see biohacker vs clinical framing in women's hormonal care for a broader discussion.
As a document that evolves. Guidelines are revised as evidence accumulates. The current versions are a snapshot of the evidence base at their publication date. Responsible clinicians treat guidelines as authoritative but not final.
For readers: if you want to understand where your own prescribing clinician sits relative to these documents, the most productive question is often direct — How do you interpret the ISSWSH guideline on testosterone for HSDD in my situation? or What's your read on the NAMS 2022 position statement? A clinician whose practice you're considering should be able to answer questions like that fluently.
footnotes
[1]: The North American Menopause Society. "The 2022 Hormone Therapy Position Statement of The North American Menopause Society." Menopause, 2022; 29(7): 767-794. [2]: Stuenkel CA, Davis SR, Gompel A, et al. "Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline." Journal of Clinical Endocrinology & Metabolism, 2015; 100(11): 3975-4011. [3]: Davis SR, Baber R, Panay N, et al. "Global Consensus Position Statement on the Use of Testosterone Therapy for Women." Journal of Clinical Endocrinology & Metabolism, 2019; 104(10): 4660-4666. [4]: Wierman ME, Arlt W, Basson R, et al. "Androgen Therapy in Women: A Reappraisal: An Endocrine Society Clinical Practice Guideline." Journal of Clinical Endocrinology & Metabolism, 2014; 99(10): 3489-3510.
Editorial & medical disclaimer
This article is published by the Pepvio editorial team for informational purposes only. It is not medical advice, diagnosis, or treatment, and it has not been reviewed by a licensed clinician. The information presented draws on published research but should not substitute for professional medical guidance. Pepvio protocols require a prescription from a licensed healthcare provider. Individual results vary. Always consult your physician before starting any new treatment protocol. Pepvio does not claim that any product cures, treats, or prevents any disease.
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