Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117468
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2005-06-30
Brief Title:
Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Phase 2 Single-Center Open-Label Randomized Controlled Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
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 single-center open-label randomized active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement
Detailed Description:
This is a 2-arm single-center open-label randomized active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period Patients will also be required to use an estrogen patch during the course of the study The overall study duration for each patient will be approximately 1½ months
Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26 In addition serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31
Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26 In addition serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31
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