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Related Experiment Videos

Progesterone administration by nasal spray.

E Cicinelli1, G Ragno, I Cagnazzo

  • 1Department of Obstetrics and Gynecology, Medical School, University of Bari, Italy.

Fertility and Sterility
|July 1, 1991
PubMed
Summary

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Nasal spray progesterone effectively reached therapeutic levels in menopausal women, demonstrating good bioavailability and patient acceptability. This study highlights the potential clinical usefulness of intranasal progesterone for hormone therapy.

Area of Science:

  • Endocrinology
  • Pharmacokinetics
  • Drug Delivery Systems

Background:

  • Menopause is associated with declining progesterone levels, leading to various symptoms.
  • Hormone replacement therapy (HRT) often includes progesterone, but traditional delivery methods can have limitations.

Purpose of the Study:

  • To investigate the bioavailability and clinical usefulness of progesterone administered via nasal spray.
  • To assess the pharmacokinetic profile of intranasal progesterone in healthy menopausal women.

Main Methods:

  • Ten healthy menopausal women received intranasal (IN) spray administration of progesterone (4 doses of 20 mg/mL oleic solution, ~11.2 mg total).
  • Circulating progesterone levels were measured over 720 minutes to determine pharmacokinetic parameters.
Keywords:
AmericasBiologyClinical ResearchContraceptionContraception ResearchDeveloped CountriesEndocrine SystemFamily PlanningHormonesNorth AmericaNorthern AmericaPhysiologyProgestational HormonesProgesterone--administraction and dosageProgesterone--pharmacodynamicsResearch MethodologyUnited States

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Main Results:

  • Maximum progesterone concentration (Cmax) of 3.75 +/- 0.214 ng/mL was reached 60 minutes post-administration.
  • Therapeutic progesterone levels (>2 ng/mL) were maintained for up to 360 minutes.
  • The area under the curve (AUC 0-720) was 1,481.6 +/- 343 ng.h/mL, indicating significant systemic exposure.

Conclusions:

  • Progesterone nasal spray administration is effective in achieving therapeutic systemic levels.
  • The nasal spray formulation of progesterone is likely clinically safe and acceptable for patients.
  • Intranasal progesterone presents a promising alternative delivery route for hormone therapy in menopausal women.