Estradiol/progesterone

Estradiol/progesterone
Estradiol (top) and progesterone (bottom)
Combination of
EstradiolEstrogen
ProgesteroneProgestogen
Clinical data
Trade namesBijuva, Juvenum, Lutes
Other namesE2/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 (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.

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]

Research

As of April 2022, a vaginal ring containing E2/P4 (developmental code names DARE-HRT1 and JNP-0201) is under development for use in menopausal hormone therapy.[20]

References

  1. ^ "Bijuva (Theramex Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 22 September 2022. Archived from the original on 12 March 2023. Retrieved 29 April 2023.
  2. ^ "Bijuva Product information". Health Canada. 25 April 2012. Archived from the original on 6 June 2022. Retrieved 5 June 2022.
  3. ^ a b c d e "Bijuva- estradiol and progesterone capsule". DailyMed. 30 June 2021. Archived from the original on 12 March 2023. Retrieved 12 March 2023.
  4. ^ a b c d "Estradiol/Progesterone - TherapeuticsMD - AdisInsight". Archived from the original on 22 October 2016. Retrieved 21 October 2016.
  5. ^ a b c 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.
  6. ^ "Bijuva (Estradiol and progesterone) FDA Approval History". Archived from the original on 3 November 2018. Retrieved 3 November 2018.
  7. ^ "First Generic Drug Approvals". U.S. Food and Drug Administration. 17 October 2022. Archived from the original on 26 January 2021. Retrieved 28 November 2022.
  8. ^ a b c "Juvenum (estradiol/progesterone) - Medicamentos PLM". Medicamentos PLM. Archived from the original on 18 September 2018. Retrieved 17 September 2018.
  9. ^ a b c "Estradiol/Progesterone injection - Laboratorios Carnot - AdisInsight". Archived from the original on 29 August 2021. Retrieved 23 December 2017.
  10. ^ "Juvenum - Drugs.com". Archived from the original on 23 December 2017. Retrieved 23 December 2017.
  11. ^ Cortés-Bonilla M, Alonso-Campero R, Bernardo-Escudero R, Francisco-Doce MT, Chavarín-González J, Pérez-Cuevas R, Chedraui P (October 2016). "Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17β-estradiol/progesterone". Gynecol. Endocrinol. 32 (10): 831–834. doi:10.1080/09513590.2016.1183628. PMID 27187320. S2CID 22688585.
  12. ^ Cortés-Bonilla M, Bernardo-Escudero R, Alonso-Campero R, Francisco-Doce MT, Hernández-Valencia M, Celis-González C, Márquez-Oñate R, Chedraui P, Uribe JA (July 2015). "Treatment of menopausal symptoms with three low-dose continuous sequential 17β-estradiol/progesterone parenteral monthly formulations using novel non-polymeric microsphere technology". Gynecol. Endocrinol. 31 (7): 552–9. doi:10.3109/09513590.2015.1019853. PMC 4776687. PMID 26062108.
  13. ^ 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.
  14. ^ 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.
  15. ^ 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. Archived (PDF) from the original on 10 August 2017. Retrieved 18 September 2018.
  16. ^ 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.
  17. ^ 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. S2CID 26021562.
  18. ^ Alvarez-Sanchez F, Brache V, Faundes A (December 1993). "Recent experience with and future directions of contraceptive implants and injectable contraceptives". Current Opinion in Obstetrics & Gynecology. 5 (6): 805–814. doi:10.1097/00001703-199312000-00016. PMID 8286694.
  19. ^ 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.
  20. ^ "Estradiol/Progesterone intravaginal ring - Dare Bioscience". AdisInsight. Springer Nature Switzerland AG. Archived from the original on 29 April 2023. Retrieved 29 April 2023.
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