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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00196391

Public ClinicalTrials.gov record NCT00196391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00196391
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Duramed Research
Industry
Enrollment
180 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2005 (Type not available)
Primary completion
Apr 2007 (Actual)
Completion
Apr 2007 (Actual)
Last update posted
Jul 30, 2014

2005 – 2007

United States locations

U.S. sites
27
U.S. states
16
U.S. cities
25
Facility City State ZIP Site status
Duramed Investigational Site Mobile Alabama 36608 —
Duramed Investigational Site Phoenix Arizona 85032 —
Duramed Investigational Site Tucson Arizona 85712 —
Duramed Investigational Site Carmichael California 95608 —
Duramed Investigational Site San Diego California 92123 —
Duramed Investigational Site San Diego California 92130 —
Duramed Investigational Site Colorado Springs Colorado 80909 —
Duramed Investigational Site Pueblo Colorado 81001 —
Duramed Investigational Site Gainesville Florida 32605 —
Duramed Investigational Site Leesburg Florida 34748 —
Duramed Investigational Site Miami Florida 33143 —
Duramed Investigational Site Atlanta Georgia 30328 —
Duramed Investigational Ste Dawsonville Georgia 30534 —
Duramed Investigational Site Douglasville Georgia 30134 —
Duramed Investigational Site Laurel Maryland 20707 —
Duramed Investigational Site St Louis Missouri 63110 —
Duramed Investigational Site Alliance Nebraska 69301 —
Duramed Investigational Site Lawrenceville New Jersey 08648 —
Duramed Investigational Site Medford Oregon 97505 —
Duramed Investigational Site Pittsburgh Pennsylvania 15206 —
Duramed Investigational Site Willow Grove Pennsylvania 19090 —
Duramed Investigational Site Columbia South Carolina 29201 —
Duramed Investigational Site Memphis Tennessee 38120 —
Duramed Investigational Site Dallas Texas 75390 —
Duramed Investigational Site Houston Texas 77030 —
Duramed Investigational Site Houston Texas 77074 —
Duramed Investigational Site Newport News Virginia 23602 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00196391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2014 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00196391 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →