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

Phase 1

Completed

• Conditions: Postmenopausal Endometrium
• Interventions: Drug: Crinone 8%; Drug: Progesterone

• Registration Number: NCT01057511
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2011-08
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-01
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crinone 8%	Crinone 8%	Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally.
progesterone	Progesterone	Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally

Primary Outcome Measures

Name	Time	Method
Primary endpoint: progesterone level in endometrium and in serum	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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China