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

2014-08-27 03:16:21 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Postmenopausal Women

Intervention

Crinone 8%, Progesterone

Location

Peking Union Medical College Hospital
Beijing
China
100730

Status

Active, not recruiting

Source

Peking Union Medical College Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

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