MedTrace Logo

Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

NCT00160199 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2010-07-07

Study results available
· View outcomes & findings →

Summary

To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Conditions

  • Secondary Amenorrhea

Interventions

DRUG

PROMETRIUM® 300 mg

300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

DRUG

PROMETRIUM® 400 mg

400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00160199 on ClinicalTrials.gov