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

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of the Differences of Progesterone Concentration in Serum and Endometrium After Administration With Vaginal and Intramuscular Progesterone

Conditions
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Postmenopausal Endometrium

Intervention / Treatment
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* Drug: Crinone 8%
* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Perimenopausal women aged <55 years old with amenorrhea>=2 months or reproductive aged women with amenorrhea >= 6months due to premature ovarian failure or other reasons.; Serum progesterone level < 1ng/mL Endometrial thickness ≥5mm No contraindication of progesterone administration; Informed consent is signed. Exclusion Criteria: The other kind of progestin was applied 1 month before recruitment; Any serious diseases that does not allow to receive the progestin treatment; Under any vaginal treatment; Any vaginal infectious disease; Any other hormone treatment contraindications; drug abuse or untreated STD; Prior hypersensitivity to Crinone or one of their excipients. Pregnant women who indicate hCG positive.

Ages Eligible for Study
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Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: progesterone<br>Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally | Drug: Progesterone<br>* Progesterone 20mg/ i.m./ Qd, 7 days totally.<br>* Other names: IMP;|
| Experimental: Crinone 8%<br>Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally. | Drug: Crinone 8%<br>* Crinone 8%, 90mg / p.v. / Qd, 7 days totally.<br>* Other names: progesterone vaginal gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crinone, progesterone, endometrial progesterone concentration