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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-02-29

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.

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Detailed Description

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Conditions

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Postmenopausal Endometrium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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progesterone

Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

Progesterone 20mg/ i.m./ Qd, 7 days totally.

Crinone 8%

Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally.

Group Type EXPERIMENTAL

Crinone 8%

Intervention Type DRUG

Crinone 8%, 90mg / p.v. / Qd, 7 days totally.

Interventions

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Crinone 8%

Crinone 8%, 90mg / p.v. / Qd, 7 days totally.

Intervention Type DRUG

Progesterone

Progesterone 20mg/ i.m./ Qd, 7 days totally.

Intervention Type DRUG

Other Intervention Names

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progesterone vaginal gel IMP

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.

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No