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| Name | Class |
|---|---|
| Merck Serono International SA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| progesterone | Active Comparator | Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally |
|
| Crinone 8% | Experimental | Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crinone 8% | Drug | Crinone 8%, 90mg / p.v. / Qd, 7 days totally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after 7 days of progesterone therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AIJUN SUN, PhD, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| D007291 | Inosine Monophosphate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Progesterone | Drug | Progesterone 20mg/ i.m./ Qd, 7 days totally. |
|
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |