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

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05730205
Collaborator
(none)
22
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nexplanon 68 MG Drug Implant
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Feb 15, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nexplanon

Drug: Nexplanon 68 MG Drug Implant
Progestin contraceptive device
No Intervention: Baseline

Outcome Measures

Primary Outcome Measures

  1. Frequency of vaso-occlusive crises [9 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05730205
Other Study ID Numbers:
  • 855708
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Anemia, Sickle Cell
Etonogestrel

Study Results

No Results Posted as of Feb 15, 2023