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Estradiol/progesterone
Pharmaceutical combination / From Wikipedia, the free encyclopedia
Estradiol/progesterone (E2/P4), sold under the brand name Bijuva among others, is a combined estrogen and progestogen medication which is used in the treatment of menopausal symptoms in postmenopausal women.[3] It contains estradiol, an estrogen, and progesterone, a progestogen, and is available in both oral and intramuscular formulations.[3] E2/P4 differs from other estrogen–progestogen formulations in that the sex-hormonal agents used are bioidentical.[medical citation needed]
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![]() Estradiol (top) and progesterone (bottom) | |
Combination of | |
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Estradiol | Estrogen |
Progesterone | Progestogen |
Clinical data | |
Trade names | Bijuva, Juvenum, Lutes |
Other names | E2/P4; TX-001HR; TX-12-001HR; CA682-2 |
License data | |
Routes of administration | By mouth, intramuscular injection |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG | |
CompTox Dashboard (EPA) |
Estradiol/progesterone is an oral combination of estradiol (E2), an estrogen, and progesterone (P4), a progestogen, which was developed by TherapeuticsMD and is approved in the United States for the treatment of menopausal symptoms in women.[4][5] It is also under development for the treatment of endometrial hyperplasia in women.[4] The medication contains 2 mg solubilized E2 and 200 mg P4 in each gelatin capsule.[5][3] It is the first combination of E2 and P4 in oral capsule form that has been developed for clinical use.[5] Bijuva is currently in phase III clinical trials for endometrial hyperplasia.[4] The medication was approved by the Food and Drug Administration for the treatment of menopausal symptoms in October 2018.[4][6][3] It is available as a generic medication.[7]
E2/P4 is available as an aqueous suspension of E2 and P4 encapsulated in microspheres for use by intramuscular injection under the brand name Juvenum in Mexico.[8][9][10] It was introduced for the treatment and prevention of menopausal symptoms like hot flashes, vulvovaginal symptoms, and osteoporosis in December 2014.[8][9] The combination contains relatively low doses of E2 and P4 (1 mg and 20 mg, respectively) contained within microspheres that results in a slower release of the hormones.[8][9] Studies of this formulation have been published.[11][12]
E2/P4 with 5 mg E2 and 150 to 300 mg P4 encapsulated in microspheres in an aqueous suspension has been studied as a once-a-month combined injectable contraceptive but has not been further developed or introduced for medical use.[13][14][15][16][17] E2/P4 with 5 mg E2 and 100 mg P4 in a macrocrystalline aqueous suspension has also been studied as a once-a-month combined injectable contraceptive, but likewise was not further developed.[18][19]