Estradiol/progesterone

Estradiol/progesterone
Estradiol (top) and progesterone (bottom)
Combination of
Estradiol Estrogen
Progesterone Progestogen
Clinical data
Trade names Juvenum
Synonyms E2/P4; TX-001HR; TX-12-001HR; CA682-2
Routes of
administration		 By mouth, intramuscular injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID

Estradiol/progesterone (E2/P4) is a combined estrogen and progestogen medication which is used in the treatment of menopausal symptoms in postmenopausal women. It contains estradiol, an estrogen, and progesterone, a progestogen. E2/P4 differs from other estrogen–progestogen formulations in that the sex-hormonal agents used are bioidentical.

TX-001HR (formerly TX-12-001HR) is an oral combination of estradiol (E2), an estrogen, and progesterone (P4), a progestogen, which is under development in the United States by TherapeuticsMD for the treatment of menopausal symptoms and endometrial hyperplasia in women.[1][2] It contains 2 mg solubilized E2 and 200 mg P4 in each gelatin capsule.[2] The drug is the first combination of E2 and P4 in oral capsule form that has been developed for clinical use.[2] It is currently in preregistration for menopausal symptoms and phase III clinical trials for endometrial hyperplasia.[1] TherapeuticsMD submitted a New Drug Application for the medication to the Food and Drug Administration for the treatment of menopausal symptoms in December 2017.[1]

E2/P4 is available as an aqueous suspension of E2 and P4 encapsulated in microspheres for use by intramuscular injection once a month under the brand name Juvenum in Mexico.[3][4][5] It was introduced for the treatment and prevention of menopausal symptoms like hot flashes, vulvovaginal symptoms, and osteoporosis in December 2014.[3][4] 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.[3][4]

E2/P4 encapsulated in microspheres has been studied for use as a once-a-month combined injectable contraceptive but has not been further developed or introduced for medical use.[6][7][8][9][10][11]

See also

References

  1. 1 2 3 http://adisinsight.springer.com/drugs/800038089
  2. 1 2 3 Pickar JH, Bon C, Amadio JM, Mirkin S, Bernick B (2015). "Pharmacokinetics of the first combination 17β-estradiol/progesterone capsule in clinical development for menopausal hormone therapy". Menopause. 22 (12): 1308–16. doi:10.1097/GME.0000000000000467. PMC 4666011. PMID 25944519.
  3. 1 2 3 "Juvenum (estradiol/progesterone) - Medicamentos PLM". Medicamentos PLM. Archived from the original on 2018-09-17. Retrieved 2018-09-17.
  4. 1 2 3 http://adisinsight.springer.com/drugs/800044558
  5. ↑ https://www.drugs.com/international/juvenum.html
  6. ↑ Toppozada MK (April 1994). "Existing once-a-month combined injectable contraceptives". Contraception. 49 (4): 293–301. doi:10.1016/0010-7824(94)90029-9. PMID 8013216.
  7. ↑ Garza-Flores J (April 1994). "Pharmacokinetics of once-a-month injectable contraceptives". Contraception. 49 (4): 347–59. doi:10.1016/0010-7824(94)90032-9. PMID 8013219.
  8. ↑ Bagade O, Pawar V, Patel R, Patel B, Awasarkar V, Diwate S (2014). "Increasing use of long-acting reversible contraception: safe, reliable, and cost-effective birth control" (PDF). World J Pharm Pharm Sci. 3 (10): 364–392. ISSN 2278-4357.
  9. ↑ Newton JR, D'arcangues C, Hall PE (1994). "A review of "once-a-month" combined injectable contraceptives". J Obstet Gynaecol (Lahore). 4 Suppl 1: S1–34. doi:10.3109/01443619409027641. PMID 12290848.
  10. ↑ Garza-Flores J, Fatinikun T, Hernandez L, Ramos I, Cardenas M, Menjivar M (July 1991). "A pilot study on the assessment of a progesterone/estradiol sustained release as once-a-month-injectable contraceptive". Contraception. 44 (1): 45–59. doi:10.1016/0010-7824(91)90105-O. PMID 1893701.
  11. ↑ Garza-Flores J, Hall PE, Perez-Palacios G (1991). "Long-acting hormonal contraceptives for women". J. Steroid Biochem. Mol. Biol. 40 (4–6): 697–704. doi:10.1016/0960-0760(91)90293-E. PMID 1958567.



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