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Effects of the Contraceptive Implant in Women With Sickle Cell Disease (SCD CURE)

Primary Purpose

Sickle Cell Disease

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nexplanon 68 MG Drug Implant
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female aged 18-45 Diagnosis of sickle cell disease (SS or SB0) Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month required for all hormonal contraception prior to enrollment in the study. Access to a device with text messaging capability Must be able to read and understand English Willing to comply with study procedures Exclusion Criteria: SC Disease Use of Depo Provera in the past 6 months Changes to sickle cell medications in the past 3 months Contraindications to use of Nexplanon device as per clinical standards Currently pregnant or pregnant within the last month or seeking to become pregnant Currently breastfeeding

Sites / Locations

  • Penn Medicine University CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Nexplanon

Baseline

Arm Description

Outcomes

Primary Outcome Measures

Frequency of vaso-occlusive crises
Self-reported pain crises, discrete pain episodes will be separated by at least 2 weeks

Secondary Outcome Measures

Full Information

First Posted
February 6, 2023
Last Updated
June 27, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05730205
Brief Title
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
Acronym
SCD CURE
Official Title
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 100,000 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nexplanon
Arm Type
Active Comparator
Arm Title
Baseline
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Nexplanon 68 MG Drug Implant
Intervention Description
Progestin contraceptive device
Primary Outcome Measure Information:
Title
Frequency of vaso-occlusive crises
Description
Self-reported pain crises, discrete pain episodes will be separated by at least 2 weeks
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female aged 18-45 Diagnosis of sickle cell disease (SS or SB0) Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month required for all hormonal contraception prior to enrollment in the study. Access to a device with text messaging capability Must be able to read and understand English Willing to comply with study procedures Exclusion Criteria: SC Disease Use of Depo Provera in the past 6 months Changes to sickle cell medications in the past 3 months Contraindications to use of Nexplanon device as per clinical standards Currently pregnant or pregnant within the last month or seeking to become pregnant Currently breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arden McAllister, MPH
Phone
267-785-8044
Email
arden.mcallister@pennmedicine.upenn.edu
Facility Information:
Facility Name
Penn Medicine University City
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arden McAllister

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of the Contraceptive Implant in Women With Sickle Cell Disease

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