TY - JOUR
T1 - Peripheral progesterone (P) levels and endometrial response to various dosages of vaginally administered P in estrogen-primed women
AU - Pasquale, Samuel A.
AU - Bachmann, Gloria
AU - Foldesy, Robin G.
AU - Blackwell, Richard E.
AU - Levine, Jeffrey
N1 - Funding Information:
Received November 20,1996; revised and accepted July 1,1997. Supported by GynoPharma Inc., grant D94-32001, Somerville, New Jersey. Presented at the 51st Annual Meeting of the American Society for Reproductive Medicine, Seattle, Washington, October 7-12, 1995. Reprint requests: Samuel A. Pasquale, M.D., Department of Obstetrics/Gynecology and Reproductive Sciences, UMDNJ-Robert Wood Johnson Medical School, 125 Paterson Street, New Brunswick, New Jersey 08901-1977 (FAX: 908-235-7035). * Department of Obstetrics/Gynecology and Reproductive Sciences, UMDNJ-Robert Wood Johnson Medical School. t GynoPharma Inc., Somerville, NJ. $ Department of Obstetrics/Gynecology, University of Alabama-Birmingham.
PY - 1997/11
Y1 - 1997/11
N2 - 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.
AB - 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.
KW - Endometrial conversion
KW - Pharmacokinetics
KW - Vaginal P
UR - http://www.scopus.com/inward/record.url?scp=0342617516&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0342617516&partnerID=8YFLogxK
U2 - 10.1016/S0015-0282(97)00329-4
DO - 10.1016/S0015-0282(97)00329-4
M3 - Article
C2 - 9389807
AN - SCOPUS:0342617516
VL - 68
SP - 810
EP - 815
JO - Fertility and Sterility
JF - Fertility and Sterility
SN - 0015-0282
IS - 5
ER -