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

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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Endometrium
• Intervention / Treatment: Drug: Progesterone; Drug: Crinone 8%

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: progesterone vaginal gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint: progesterone level in endometrium and in serum	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.	after 7 days of progesterone therapy

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Merck Serono International SA
• Investigators: Principal Investigator: AIJUN SUN, PhD, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (ESTIMATE): January 27, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 3, 2012
• Last Update Submitted That Met QC Criteria: April 1, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: progesterone; Crinone; endometrial progesterone concentration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: EMR200113-600