MedTrace Logo

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

NCT00196391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2014-07-30

No results posted yet for this study

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.

Conditions

  • Amenorrhea

Interventions

DRUG

DR-2021a

1 capsule daily for 10 days

DRUG

DR-2021b

1 capsule daily for 10 days

DRUG

DR-2021c

1 capsule daily for 10 days

DRUG

DR-2021d

1 capsule daily for 10 days

DRUG

DR-2021e

1 capsule daily for 10 days

OTHER

Placebo

1 matching placebo capsule for 10 days

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Principal Investigators

  • Duramed Protocol Chair · Duramed Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-04-30
Completion
2007-04-30

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 NCT00196391 on ClinicalTrials.gov