Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration
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.
Drug: Crinone 8%
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Investigation of the Differences of Progesterone Concentration in Serum and Endometrium After Administration With Vaginal and Intramuscular Progesterone|
- Primary endpoint: progesterone level in endometrium and in serum [ Time Frame: after 7 days of progesterone therapy ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||December 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Active Comparator: progesterone
Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally
Progesterone 20mg/ i.m./ Qd, 7 days totally.
Other Name: IMP
Experimental: Crinone 8%
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.
Other Name: progesterone vaginal gel
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057511
|Peking Union Medical College Hospital|
|Beijing, China, 100730|
|Principal Investigator:||AIJUN SUN, PhD, MD||Peking Union Medical College Hospital|