Peripheral progesterone (P) levels and endometrial response to various dosages of vaginally administered P in estrogen-primed women

Samuel A. Pasquale, Gloria Bachmann, Robin G. Foldesy, Richard E. Blackwell, Jeffrey Levine

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Objective: To compare the pharmacokinetics and pharmacodynamics of 100 mg/d, 200 mg/d, and 400 mg/d (200 mg two times per day) of P administered vaginally for 14 days to estrogen-primed postmenopausal women. Design: Randomized, open-label, three-way crossover study. Setting: Two university- based investigative sites. Patient(s): Twenty healthy postmenopausal women with histologically normal endometria. Intervention(s): Oral 17β-E2 was given each day of a 28-day cycle; a P vaginal suppository was inserted daily according to the randomization schedule during days 15-28 of each cycle; blood samples were collected; an endometrial biopsy was obtained on day 25; and patients were crossed over to the next treatment cycle after a washout period of at least 30 days. Main Outcome Measure(s): Mean P blood levels, endometrial dating/conversion. Result(s): There was good vaginal absorption of P for all dosages. Endometrial conversion occurred in all 200- and 400- mg/d P-dosed cycles, whereas the 100-mg/d dosage failed to convert primed endometria consistently. There also was a significantly increased tendency for earlier bleeding and spotting with the 100-mg/d dosage. Conclusion(s): Both the 200- and 400-mg/d dosage regimens consistently convert an estrogen- primed endometrium, and yield appropriate endometrial dating and bleeding patterns. However, the 400-mg/d dosage attains the highest sustained blood levels and may be the best dosage regimen for further study.

Original languageEnglish (US)
Pages (from-to)810-815
Number of pages6
JournalFertility and Sterility
Volume68
Issue number5
DOIs
StatePublished - Nov 1997

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology

Keywords

  • Endometrial conversion
  • Pharmacokinetics
  • Vaginal P

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