Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730205
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-02-06
Brief Title:
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SCD CURE
Brief Summary:
The objective of this study is to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises quality of life and hematologic parameters in women with SCD
Detailed Description:
Sickle cell disease SCD is the most common inherited blood disorder in the United States affecting 100000 primarily Black people The disease is characterized by chronic pain and infection and ultimately reduces life expectancy by 20 years compared to people without SCD Given the importance of effective contraception for women with sickle cell disease as well as previously demonstrated therapeutic benefits of hormonal contraception the etonogestrel implant may be an optimal method of contraception for women with SCD
This study aims to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises quality of life and hematologic parameters in women with SCD
This is a crossover study Participants will be observed over two phases 1 a 3-month phase with no hormonal contraceptive intervention and 2 a 6-month phase with the progestin implant During the phase with no hormonal contraceptive intervention participants must be willing to be abstinent or use a barrier method or they must have had a permanent contraception procedure such as a tubal ligation or salpingectomy or be using the copper intrauterine device
This study aims to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises quality of life and hematologic parameters in women with SCD
This is a crossover study Participants will be observed over two phases 1 a 3-month phase with no hormonal contraceptive intervention and 2 a 6-month phase with the progestin implant During the phase with no hormonal contraceptive intervention participants must be willing to be abstinent or use a barrier method or they must have had a permanent contraception procedure such as a tubal ligation or salpingectomy or be using the copper intrauterine device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None