Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139685
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2005-08-29
Brief Title:
Depo-Provera Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Depo-Provera Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls
Status:
COMPLETED
Status Verified Date:
2008-09
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:
To evaluate and compare Bone Mineral Density BMD in adolescent Depo-Provera Contraceptive Injection DP150CI users during depo medroxyprogesterone acetate DMPA therapy and following discontinuation of DMPA Another group electing non-hormonal contraception or abstinence will be recruited as a reference population across all study sites The primary variable is BMD measured by Dual Energy X-ray Absorptiometry DXA Secondary variables are Total Body Composition Total Body Calcium TBC measured by Dual Energy X-ray Absorptiometry DXA and surrogate biologic BMD markers Safety will be evaluated by adverse event reporting laboratory evaluations pregnancies weight and vital signs
Detailed Description:
None
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