drugset / Trial / NCT01057511

Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration

NCT01057511

RandomizedParallel-groupSingle-blindTreatment

Summary

Crinone is a micronized progesterone gel which is administrated via vaginal route and targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration. This study is to investigate the difference of progesterone concentration in serum and endometrium after administration with crinone and intramuscular progesterone. The study will be conducted as a single centre, randomized, active controlled study. Recruitment duration will be 6-8 months long. Day 1 of Crinone administration will be the baseline. On Day 7 of Crinone administration endometrial tissue will be taken for P4 test. Last visit will be at 3-5 days after withdraw bleeding.

Timeline

Start
2009-12
Primary completion
2011-08
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Progesterone Other / unclassified 20 mg Other
Subject Progesterone Other / unclassified 90 mg Other

Indications

No indication recorded.