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

NCT01057511 | Completed Phase 1 DMC

• 1 other identifier: EMR200113-600
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Endometrium

Keywords

Crinone; progesterone; endometrial progesterone concentration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

progesterone

ACTIVE COMPARATOR

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

Drug: Progesterone

Crinone 8%

EXPERIMENTAL

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

Drug: Crinone 8%

Interventions

Crinone 8% DRUG

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

Also known as: progesterone vaginal gel

Crinone 8%

Progesterone DRUG

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

Also known as: IMP

progesterone

Eligibility Criteria

• Age: Up to 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Merck Serono International SA: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Interventions

Progesterone; Inosine Monophosphate

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• AIJUN SUN, PhD, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: February 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

CN (1)