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

Completed · Phase 2 · Has a placebo group

Conditions studied: Amenorrhea

In brief

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.

Key facts

Study ID

NCT00196391

Run by

Duramed Research

People needed

180

Starts

2005-09-01

Expected to finish

2007-04-01

Last updated by the study team

2014-07-30

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Not pregnant
• Secondary amenorrhea or oligomenorrhea of at least 50 days duration
• Not currently on any hormonal medication
• Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom)

You may not qualify if…

• Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months
• Use of any hormonal birth control within the last 3 months
• Any contraindication to the use of progestins

Where it is running

• Duramed Investigational Site — Mobile, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Carmichael, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — Colorado Springs, Colorado, United States
• Duramed Investigational Site — Pueblo, Colorado, United States
• Duramed Investigational Site — Gainesville, Florida, United States
• Duramed Investigational Site — Leesburg, Florida, United States
• Duramed Investigational Site — Miami, Florida, United States
• Duramed Investigational Site — Atlanta, Georgia, United States
• Duramed Investigational Ste — Dawsonville, Georgia, United States
• Duramed Investigational Site — Douglasville, Georgia, United States
• Duramed Investigational Site — Laurel, Maryland, United States
• Duramed Investigational Site — St Louis, Missouri, United States
• Duramed Investigational Site — Alliance, Nebraska, United States
• Duramed Investigational Site — Lawrenceville, New Jersey, United States
• Duramed Investigational Site — Medford, Oregon, United States
• Duramed Investigational Site — Pittsburgh, Pennsylvania, United States
• Duramed Investigational Site — Willow Grove, Pennsylvania, United States
• Duramed Investigational Site — Columbia, South Carolina, United States
• Duramed Investigational Site — Memphis, Tennessee, United States
• Duramed Investigational Site — Dallas, Texas, United States
• Duramed Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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