A Phase 1/2 interventional study of Crinone 8% and Progesterone in Postmenopausal Endometrium, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to female participants aged Up to 55 Years. Per ClinicalTrials.gov, last updated 2012-04-03.
Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Treatment
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.
Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Exclusion Criteria:
Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally
Drug: Progesterone
Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally.
Drug: Crinone 8%
Crinone 8%, 90mg / p.v. / Qd, 7 days totally.
Also known as: progesterone vaginal gel
Progesterone 20mg/ i.m./ Qd, 7 days totally.
Also known as: IMP
Primary endpoint: progesterone level in endometrium and in serum
The women who singed informed consent were randomized into two groups, respectively received Crinone 90mg via vaginal route or progesterone 20mg via IM route, once per day, for seven days. After 7 days therapy, endometrium biopsy was taken via vaginal route for tissue P concentration test by radioimmunoassay method. Blood sample were drawn for serum progesterone level.
Time frame: after 7 days of progesterone therapy
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital