Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196391
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2005-09-13
Brief Title:
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Patients will be treated for 10 days and study participation will be approximately 24 days Patients will undergo a physical exam including a pelvic and breast exam Patients will be required to complete bleeding and spotting information daily in a diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None