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NCT Number: NCT06665997

Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease

This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease.

Participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain. They will complete a 3-month "baseline "with no use of hormonal contraception, and then a 3-month follow-up after receiving an injection of Depo-Provera. Participants will complete 6 to 7 in-person visits with a urine pregnancy test, blood draw, and surveys, as well as complete remote weekly surveys and monthly home pregnancy tests.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Emory University, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Female, aged 18-50 years old
  • Diagnosis of sickle cell disease (SS, SB0,SB+,SC)
  • Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months
  • At least 1 and no more than 10 medical presentations (e.g. hospitalization, emergencyroom visit, outpatient infusion visit) for vaso-occlusive pain during the past year, unless approved by study PI Andrea Roe
  • Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month since last use of all hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study.
  • Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days.
  • Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months
  • Access to a device with text-messaging capability
  • Must be able to read and understand English
  • Willing to comply with study procedures

Exclusion criteria

  • Chronic inflammatory conditions, such as lupus or inflammatory bowel disease
  • History of VTE or stroke
  • Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation
  • Current use of hormonal contraception or the copper intrauterine device
  • Current pregnancy or pregnancy within the last 6 months
  • Current lactation
  • Polycystic ovary syndrome or irregular periods
  • Blood pressure >= 160 systolic or >=100 diastolic at screening visit
  • Has a history or current evidence of any condition, therapy, or other circumstance that in the opinion of the investigator exposes the participant to risk through participating in the trial, may confound the results of the trial, or could interfere with participation for the full duration of the trial.

Treatment and study plan

Depot medroxyprogesterone acetate (DMPA)

Drug

150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension

Primary outcomes

  1. Frequency of acute vaso-occlusive episodes

    Time frame: 6 months

    The primary outcome is frequency of VOEs during each phase (baseline and intervention). A VOE is self-reported by the participant. Discrete pain episodes will be separated by at least 2 weeks from one other.

    During both the baseline and intervention study phases, participants will provide weekly reports via electronic survey of vaso-occlusive pain. VOE will be defined as self-reported typical SCD pain that interferes with usual daily activities or requires emergency care or hospitalization, with distinct episodes separated by at least 2 weeks without pain.

Secondary outcomes

  1. C-reactive protein

    Time frame: 6 months

    C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

  2. Hemoglobin

    Time frame: 6 months

    Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

  3. Reticulocyte count

    Time frame: 6 months

    Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

  4. Platelet count

    Time frame: 6 months

    Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

  5. Fetal hemoglobin

    Time frame: 6 months

    Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

  6. Bilirubin

    Time frame: 6 months

    Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

  7. D-dimer

    Time frame: 6 months

    D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

  8. von Willebrand factor

    Time frame: 6 months

    von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

Study contacts

Contact information is provided by the study sponsor or research team.

Arden McAllister, MPH

CONTACT

[email protected]

267-785-8044

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Emory University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: SCD Depo

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 30, 2024
Registry last updated
May 28, 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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