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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01057511
First received: January 26, 2010
Last updated: April 1, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Postmenopausal Endometrium
Drug: Crinone 8%
Drug: Progesterone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Primary endpoint: progesterone level in endometrium and in serum [ Time Frame: after 7 days of progesterone therapy ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 51
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057511

Locations
China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Merck Serono International SA
Investigators
Principal Investigator: AIJUN SUN, PhD, MD Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01057511     History of Changes
Other Study ID Numbers: EMR200113-600
Study First Received: January 26, 2010
Last Updated: April 1, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College Hospital:
Crinone
progesterone
endometrial progesterone concentration

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014