Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086177
Status:
COMPLETED
Last Update Posted:
2010-08-19
First Post:
2004-06-25
Brief Title:
Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
Sponsor:
Juniper Pharmaceuticals Inc
Organization:
Juniper Pharmaceuticals Inc
Study Overview
Official Title:
A Phase III Randomized Double-blind Placebo-controlled Multi-center Study to Assess the Efficacy Safety and Tolerability of 8 Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery
Status:
COMPLETED
Status Verified Date:
2010-08
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 research study is being conducted at over 12 pregnancy research centers in the US The study will compare an investigational treatment with a placebo a treatment without medication Neither the investigators nor the patients in the trial will know which treatment has been assigned All study medications will be given vaginally once a day Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36
Detailed Description:
Patients who participate are to have
A single baby pregnancy no twins or triplets allowed
Patients will start treatment before pregnancy week 23
Patients must have a previous preterm birth a preemie
Patients must be 18-45 years of age
A single baby pregnancy no twins or triplets allowed
Patients will start treatment before pregnancy week 23
Patients must have a previous preterm birth a preemie
Patients must be 18-45 years of age
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