A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
NCT ID: NCT00196391
Last Updated: 2014-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2005-09-30
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
DR-2021a
1 capsule daily for 10 days
2
DR-2021b
1 capsule daily for 10 days
3
DR-2021c
1 capsule daily for 10 days
4
DR-2021d
1 capsule daily for 10 days
5
DR-2021e
1 capsule daily for 10 days
6
Placebo
1 matching placebo capsule for 10 days
Interventions
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DR-2021a
1 capsule daily for 10 days
DR-2021b
1 capsule daily for 10 days
DR-2021c
1 capsule daily for 10 days
DR-2021d
1 capsule daily for 10 days
DR-2021e
1 capsule daily for 10 days
Placebo
1 matching placebo capsule for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Use of any hormonal birth control within the last 3 months
* Any contraindication to the use of progestins
18 Years
50 Years
FEMALE
No
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Duramed Research, Inc.
Principal Investigators
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Duramed Protocol Chair
Role: STUDY_CHAIR
Duramed Research, Inc.
Locations
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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
Duramed Investigational Site
Houston, Texas, United States
Duramed Investigational Site
Newport News, Virginia, United States
Countries
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Other Identifiers
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DR-MPG-201
Identifier Type: -
Identifier Source: org_study_id
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