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

Information source: Peking Union Medical College Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Endometrium

Intervention: Crinone 8% (Drug); Progesterone (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Peking Union Medical College Hospital

Official(s) and/or principal investigator(s):
AIJUN SUN, PhD, MD, Principal Investigator, Affiliation: Peking Union Medical College Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Primary endpoint: progesterone level in endometrium and in serum


Minimum age: N/A. Maximum age: 55 Years. Gender(s): Female.


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.

Locations and Contacts

Peking Union Medical College Hospital, Beijing 100730, China
Additional Information

Starting date: December 2009
Last updated: April 1, 2012

Page last updated: August 23, 2015

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