Impact of a contraceptive implant on women with sickle cell disease
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
This study is testing whether a contraceptive implant can help women with sickle cell disease feel better and have fewer pain episodes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05730205 on ClinicalTrials.gov |
What this trial studies
This study evaluates the acceptability and effects of the etonogestrel contraceptive implant on women with sickle cell disease (SCD). It aims to assess how the implant influences the frequency of vaso-occlusive crises, quality of life, and hematologic parameters. Participants will undergo a crossover design with a 3-month phase without hormonal contraception followed by a 6-month phase with the implant. The study targets women aged 18-45 who experience regular pain episodes due to SCD.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with a diagnosis of sickle cell disease who experience at least one vaso-occlusive pain episode per month.
Not a fit: Patients with sickle cell disease type SC or those who have used Depo Provera in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective contraceptive option that may also reduce pain crises and improve quality of life for women with sickle cell disease.
How similar studies have performed: Other studies have shown positive outcomes with hormonal contraception in managing symptoms of sickle cell disease, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Penn Medicine University City — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Arden McAllister, MPH
- Email: arden.mcallister@pennmedicine.upenn.edu
- Phone: 267-785-8044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.