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Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

NCT01176175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-10-13

No results posted yet for this study

Summary

Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to induce transformation from a proliferative endometrium to a secretory endometrium.

Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.

Sites: 1 Subjects: 48 postmenopausal women.

Conditions

Interventions

DRUG

Progesterone

Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.

DRUG

Progesterone

Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.

DRUG

Progesterone

Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.

DRUG

Progesterone

Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.

Sponsors & Collaborators

  • Productos Científicos S. A. de C. V.

    lead INDUSTRY

Principal Investigators

  • Roberto Bernardo, MD MSc · Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01176175 on ClinicalTrials.gov