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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postmenopausal Endometrium

Treatments: Drug: Crinone 8%; Drug: Progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01057511

EMR200113-600

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Female

Ages: Under 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

progesterone

Active Comparator group

Description:

Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally

Treatment:

Drug: Progesterone

Crinone 8%

Experimental group

Description:

Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally.

Treatment:

Drug: Crinone 8%