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OpenTrials
Completed

NCT Number: NCT01057511

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

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.

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Key information

Conditions

Postmenopausal Endometrium

Age range

Up to 55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crinone 8%

Drug

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

Other names: progesterone vaginal gel

Progesterone

Drug

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

Other names: IMP

Primary outcomes

  1. Primary endpoint: progesterone level in endometrium and in serum

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Merck Serono International SA

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 27, 2010
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.