Clinical trial NCT05730205: Effects of the Contraceptive Implant in Women With Sickle Cell Disease
Official title: Effects of the Contraceptive Implant in Women With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sickle Cell Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of vaso-occlusive crises
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine University City
state: Pennsylvania
Study officials:
References: