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

NCT01057511 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2012-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Postmenopausal Endometrium

Interventions

DRUG

Crinone 8%

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

DRUG

Progesterone

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

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • AIJUN SUN, PhD, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-08-31
Completion
2012-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057511 on ClinicalTrials.gov