A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea

Status Completed

Clinical Trial Summary

This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.

Clinical Trial Description

In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Amenorrhea

Clinical Trial Details

NCT number	NCT00196391
Study type	Interventional
Source	Teva Pharmaceutical Industries
Contact
Status	Completed
Phase	Phase 2
Start date	September 2005
Completion date	April 2007

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