Glossary · Treatments

FDA-approved HRT

Definition: FDA-approved HRT refers to hormone therapy products mass-produced by drug manufacturers and approved by the FDA — patches, gels, sprays, tablets, vaginal preparations, and rings. Each batch is tested for dose accuracy and stability. ClearedRx prescribes FDA-approved HRT as the default and uses compounded preparations only when clinically warranted.

Detailed definition

FDA-approved HRT undergoes the standard drug approval process: pharmacokinetic studies, dose-finding trials, randomized efficacy and safety studies, and ongoing batch testing for potency and stability. FDA-approved bioidentical estradiol options include patches (Climara, Vivelle-Dot, Minivelle, generic), gels (Estrogel, Divigel, Elestrin), spray (Evamist), oral tablets (Estrace, generic), vaginal cream (Estrace), vaginal tablets (Vagifem, Yuvafem), vaginal inserts (Imvexxy), and the vaginal ring (Estring, Femring). Conjugated equine estrogens (Premarin) is FDA-approved but not bioidentical. FDA-approved progesterone is bioidentical micronized progesterone (Prometrium). FDA-approved progestins include medroxyprogesterone (Provera) and norethindrone. Combination products include Climara Pro (estradiol + levonorgestrel patch) and Combipatch (estradiol + norethindrone patch).

Why it matters in menopause

For most women, an FDA-approved product fits clinical needs and offers the assurance of batch-tested dose accuracy. ClearedRx defaults to FDA-approved products and is transparent about why a compounded option might be considered when relevant.

Sources

External references: Wikipedia.

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