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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. Identifier: NCT01057511
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : April 3, 2012
Merck Serono International SA
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Endometrium Drug: Crinone 8% Drug: Progesterone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Differences of Progesterone Concentration in Serum and Endometrium After Administration With Vaginal and Intramuscular Progesterone
Study Start Date : December 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: progesterone
Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally
Drug: Progesterone
Progesterone 20mg/ i.m./ Qd, 7 days totally.
Other Name: IMP

Experimental: Crinone 8%
Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally.
Drug: Crinone 8%
Crinone 8%, 90mg / p.v. / Qd, 7 days totally.
Other Name: progesterone vaginal gel

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057511

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Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Merck Serono International SA
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Principal Investigator: AIJUN SUN, PhD, MD Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital Identifier: NCT01057511    
Other Study ID Numbers: EMR200113-600
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012
Keywords provided by Peking Union Medical College Hospital:
endometrial progesterone concentration
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs