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Am J Obstet Gynecol. 1979 Nov 1;135(5):647-50.

A comparison of medroxyprogesterone serum concentrations by the oral or intramuscular route in patients with persistent or recurrent endometrial carcinoma.

Abstract

A randomized study, comparing serum medroxyprogesterone concentrations by the oral and intramuscular routes, was performed on 22 patients with persistent or recurrent endometrial adenocarcinoma by six institutions of the Gynecologic Oncology Group. The oral group (11 patients) received cutaneous Provera (medroxyprogesterone), 50 mg three times a day, and the intramuscular group (11 patients) received 300 mg of Depo-Provera (medroxyprogesterone) weekly for at least 2 months. Serum levels were evaluated at 0, 2, 4, 6, 8, 10, and 12 hours after administration and every day for the first week and weekly thereafter for 8 weeks. The mean serum levels (nanograms per milliliter) of medroxyprogesterone in the oral group were consistently higher than the corresponding mean levels of the intramuscular group. In addition, from the first through eighth weeks, the measurements (medians) for the oral group were statistically higher than those for the intramuscular group. Although the study indicates a significant increase in serum levels achieved by the oral route, the follow-up period of patients under study is too early to evaluate its clinical effectiveness as compared to the intramuscular route.

PIP:

22 patients with persistent or recurrent endometrial adenocarcinoma being seen by the 6 institutions of the Gynecologic Oncology Group were studied in a randomized way to compare serum levels of medroxyprogesterone after oral and intramuscular administration. Regimen A, the oral group, consisted of 11 patients who received cutaneous Provera in 50-mg doses 3 times per day; the intramuscular group, Regimen B, consisted of the other 11 subjects who received 300-mg doses of Depo-Provera weekly for at least 2 months. 3 ml of blood was drawn for both regimen groups at 0,2,4,6,8,10, and 12 hours after administration on Day 1, daily thereafter for the 1st week, and weekly thereafter for the course of the study. Mean serum levels of medroxyprogesterone, measured by radioimmoassay in ng/ml, were consistently higher in the oral group than the corresponding mean levels in the intramuscular group. Also, from Weeks 1-8, the medians for the oral group were statistically higher than those for Regimen B. The apparent efficacy of the oral route is indicated, but its clinical effectiveness remains untested, for this study has limited follow-up time.

PMID:
507117
[PubMed - indexed for MEDLINE]
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