Status:
COMPLETED
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
Lead Sponsor:
Duramed Research
Conditions:
Amenorrhea
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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.
Detailed Description
In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. P...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00196391
Start Date
September 1 2005
End Date
April 1 2007
Last Update
July 30 2014
Active Locations (27)
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1
Duramed Investigational Site
Mobile, Alabama, United States, 36608
2
Duramed Investigational Site
Phoenix, Arizona, United States, 85032
3
Duramed Investigational Site
Tucson, Arizona, United States, 85712
4
Duramed Investigational Site
Carmichael, California, United States, 95608