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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01057511
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : April 3, 2012
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE January 27, 2010
Last Update Posted Date April 3, 2012
Study Start Date  ICMJE December 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
Primary endpoint: progesterone level in endometrium and in serum [ Time Frame: after 7 days of progesterone therapy ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
Primary endpoint: To measure the progesterone concentration in serum and endometrial tissue. [ Time Frame: 2009Dec-2011Feb ]
Change History Complete list of historical versions of study NCT01057511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration
Official Title  ICMJE Investigation of the Differences of Progesterone Concentration in Serum and Endometrium After Administration With Vaginal and Intramuscular Progesterone
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Endometrium
Intervention  ICMJE
  • Drug: Crinone 8%
    Crinone 8%, 90mg / p.v. / Qd, 7 days totally.
    Other Name: progesterone vaginal gel
  • Drug: Progesterone
    Progesterone 20mg/ i.m./ Qd, 7 days totally.
    Other Name: IMP
Study Arms  ICMJE
  • Active Comparator: progesterone
    Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally
    Intervention: Drug: Progesterone
  • Experimental: Crinone 8%
    Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally.
    Intervention: Drug: Crinone 8%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2012)
51
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2010)
50
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057511
Other Study ID Numbers  ICMJE EMR200113-600
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Merck Serono International SA
Investigators  ICMJE
Principal Investigator: AIJUN SUN, PhD, MD Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP