TABLE 8-1Common Indications and Contraindications for FDA-Approved Bioidentical Hormone Therapy Products

Bioidentical HormoneBrand NamePreparationLabel IndicationsContraindications
17β-estradiolEstracePillModerate to severe vasomotor symptoms; moderate to severe symptoms of vulvar and vaginal atrophy; hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; prevention of osteoporosisUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; Active or recent (e.g., within the past year) arterial thromboembolic disease; Known sensitivity to FD&C Yellow No. 5 (tartrazine)
17β-estradiolAloraPatchModerate to severe vasomotor symptoms; moderate to severe symptoms of vulvar and vaginal atrophy; hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; prevention of osteoporosisUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; Active or recent (e.g., within the past year) arterial thromboembolic disease; Known hypersensitivity to product or its ingredients
17β-estradiolClimaraPatchModerate to severe vasomotor symptoms; moderate to severe symptoms of vulvar and vaginal atrophy; hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; prevention of osteoporosisUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; Active or history of arterial thromboembolic disease; High risk of venous thrombosis or arterial thrombosis; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
17β-estradiolVivelle-DotPatchModerate to severe vasomotor symptoms; moderate to severe symptoms of vulvar and vaginal atrophy; hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; prevention of osteoporosisUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Known hypersensitivity to product or its ingredients
17β-estradiolMinivellePatchModerate to severe vasomotor symptoms; prevention of osteoporosisUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Known hypersensitivity to product or its ingredients
17β-estradiolMenostarPatchPrevention of osteoporosisUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
17β-estradiolEstrogelGelModerate to severe vasomotor symptoms; moderate to severe symptoms of vulvar and vaginal atrophyUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Anaphylactic reaction or angioedema with product
17β-estradiolElestrinGelModerate to severe vasomotor symptomsUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Anaphylactic reaction or angioedema with product
17β-estradiolDivigelGelModerate to severe vasomotor symptomsUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Known hypersensitivity to product or its ingredients; Anaphylactic reaction or angioedema with product
17β-estradiolEstraceVaginal creamModerate to severe vulvar and vaginal atrophy due to menopauseUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Anaphylactic reaction or angioedema with product
17β-estradiolEstringVaginal ringModerate to severe vulvar and vaginal atrophy due to menopauseUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Known hypersensitivity to product or its ingredients; Anaphylactic reaction or angioedema with product
17β-estradiolEvamistSprayModerate to severe vasomotor symptomsUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Anaphylactic reaction or angioedema with product
17β-estradiolImvexxyVaginal tabletModerate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopauseUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Anaphylactic reaction or angioedema with product
Estradiol cypionateDepo-estradiolInjectionModerate to severe vasomotor symptoms; hypoestrogenism due to hypogonadismUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; Recent (e.g., within the past year) arterial thromboembolic disease; Known hypersensitivity to product or its ingredients
Micronized progesteronePrometriumPillPrevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets; also indicated for use in secondary amenorrheaHistory of arterial thromboembolic disease; Undiagnosed abnormal genital bleeding; Known, suspected, or history of cancer of the breast; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease
Micronized progesteroneCrinoneVaginal gelSupplementation or replacement as part of an assisted reproductive technology (ART) treatment for infertile women with progesterone deficiency (8%); secondary amenorrhea (4% and 8%)Undiagnosed vaginal bleeding; Liver dysfunction or disease; Known or suspected malignancy of the breast or genital organs; Missed abortion; Known sensitivity or hypersensitivity to product or its ingredients
Micronized progesteroneProchieveVaginal gelSupplementation or replacement as part of an assisted reproductive technology (ART) treatment for infertile women with progesterone deficiency (8%); secondary amenorrhea (4% and 8%)Undiagnosed vaginal bleeding; Liver dysfunction or disease; Known or suspected malignancy of the breast or genital organs; Missed abortion; Known sensitivity or hypersensitivity to product or its ingredients
Micronized progesteroneEndometrinOvulesTo support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile womenHistory of arterial thromboembolic disease; Known allergic reaction; Undiagnosed vaginal bleeding; Liver dysfunction or disease; History of arterial thromboembolic disease; Known or suspected malignancy of the breast or genital organs; Ectopic pregnancy or missed abortion; Known allergic reactions
17β-estradiol and micronized progesteroneBijuvaPillModerate to severe vasomotor symptoms due to menopauseUndiagnosed vaginal bleeding; Known, suspected, or history of breast cancer; Known or suspected estrogen-dependent neoplasia; Active deep vein thrombosis, pulmonary embolism, or history of these conditions; Liver dysfunction or disease; Known or suspected pregnancy; History of arterial thromboembolic disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; Known hypersensitivity to product or its ingredients; Anaphylactic reaction or angioedema with product
TestosteroneTestimGelIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding
TestosteroneVogelxoGelIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding
TestosteroneAndrogelGelIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding; Pregnant women need to be aware of the potential for transfer of testosterone from men
TestosteroneFortestaGelIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding
TestosteroneNatestoNasal gelIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding
TestosteroneAndrodermPatchIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding
TestosteroneStriantTablet (buccal system)Indicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding
TestosteroneTestopelPelletIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding
Testosterone cypionateDepoTestosteroneInjectionIndicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosteroneCarcinoma of the breast or known or suspected carcinoma of the prostate; Pregnancy or breastfeeding; Known hypersensitivity to the drug; serious cardiac, hepatic, or renal disease
Dehydroepiandrosterone (DHEA; also known as Prasterone)IntrarosaVaginal insertIndicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopauseUndiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent, or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment

NOTE: This table is limited to products that include only those active ingredients identified in the committee's Statement of Task at the time of publication.

SOURCE: NLM, 2020.

From: 8, The Use of Compounded Bioidentical Hormone Therapy

Cover of The Clinical Utility of Compounded Bioidentical Hormone Therapy
The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy; Jackson LM, Parker RM, Mattison DR, editors.
Washington (DC): National Academies Press (US); 2020 Jul 1.
Copyright 2020 by the National Academy of Sciences. All rights reserved.

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