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NCT Number: NCT05730205

Effects of the Contraceptive Implant in Women With Sickle Cell Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Penn Medicine University City

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female aged 18-45
  • Diagnosis of sickle cell disease (SS, SB 0, SB+, SC)
  • 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

  • Use of Depo Provera in the past 6 months
  • Changes to sickle cell medications in the past 3 months
  • Regular blood transfusions
  • History of hematopoeitic stem cell transplantation
  • Contraindications to use of Nexplanon device as per clinical standards (not including history of venous thromboemblosim [VTE])
  • Currently pregnant or pregnant within the last month or seeking to become pregnant
  • Currently breastfeeding

Treatment and study plan

Nexplanon 68 MG Drug Implant

Drug

Progestin contraceptive device

Primary outcomes

  1. Frequency of vaso-occlusive crises

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: SCD CURE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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