A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
1 other identifier
interventional
180
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2005
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJuly 30, 2014
May 1, 2014
1.6 years
September 13, 2005
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Throughout study period
Secondary Outcomes (1)
Time to onset, duration, and severity of withdrawal bleeding.
Throughout study
Study Arms (6)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (27)
Duramed Investigational Site
Mobile, Alabama, 36608, United States
Duramed Investigational Site
Phoenix, Arizona, 85032, United States
Duramed Investigational Site
Tucson, Arizona, 85712, United States
Duramed Investigational Site
Carmichael, California, 95608, United States
Duramed Investigational Site
San Diego, California, 92123, United States
Duramed Investigational Site
San Diego, California, 92130, United States
Duramed Investigational Site
Colorado Springs, Colorado, 80909, United States
Duramed Investigational Site
Pueblo, Colorado, 81001, United States
Duramed Investigational Site
Gainesville, Florida, 32605, United States
Duramed Investigational Site
Leesburg, Florida, 34748, United States
Duramed Investigational Site
Miami, Florida, 33143, United States
Duramed Investigational Site
Atlanta, Georgia, 30328, United States
Duramed Investigational Ste
Dawsonville, Georgia, 30534, United States
Duramed Investigational Site
Douglasville, Georgia, 30134, United States
Duramed Investigational Site
Laurel, Maryland, 20707, United States
Duramed Investigational Site
St Louis, Missouri, 63110, United States
Duramed Investigational Site
Alliance, Nebraska, 69301, United States
Duramed Investigational Site
Lawrenceville, New Jersey, 08648, United States
Duramed Investigational Site
Medford, Oregon, 97505, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Duramed Investigational Site
Willow Grove, Pennsylvania, 19090, United States
Duramed Investigational Site
Columbia, South Carolina, 29201, United States
Duramed Investigational Site
Memphis, Tennessee, 38120, United States
Duramed Investigational Site
Dallas, Texas, 75390, United States
Duramed Investigational Site
Houston, Texas, 77030, United States
Duramed Investigational Site
Houston, Texas, 77074, United States
Duramed Investigational Site
Newport News, Virginia, 23602, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duramed Protocol Chair
Duramed Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
September 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
July 30, 2014
Record last verified: 2014-05