Effects of the Contraceptive Implant in Women With Sickle Cell Disease

NCT05730205 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 855708
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Frequency of vaso-occlusive crises

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

  9 months

Study Arms (2)

Nexplanon

ACTIVE COMPARATOR

Drug: Nexplanon 68 MG Drug Implant

Baseline

NO INTERVENTION

Interventions

Nexplanon 68 MG Drug Implant DRUG

Progestin contraceptive device

Nexplanon

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine University City

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

etonogestrel; Drug Implants

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Arden McAllister, MPH

CONTACT

267-785-8044; arden.mcallister@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)