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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01057511

Enrollment

Registered

2010-01-27

Start date

2009-12-31

Completion date

2012-02-29

Last updated

2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Endometrium

Keywords

Crinone, progesterone, endometrial progesterone concentration

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.

Interventions

DRUGCrinone 8%

Crinone 8%, 90mg / p.v. / Qd, 7 days totally.

DRUGProgesterone

Progesterone 20mg/ i.m./ Qd, 7 days totally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026