Sickle Cell Disease (SCD)Phase 4SCD DepoNCT06665997
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
A Phase 4 study testing Depot medroxyprogesterone acetate (DMPA) in people with Sickle Cell Disease (SCD) and Vaso-Occlusive Pain Episode in Sickle Cell Disease, run by University of Pennsylvania at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
- What is being tested?
- Depot medroxyprogesterone acetate (DMPA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jun 2025to 31 Jul 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Hailly Butler, 404-712-8895, hailly.butler@emory.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Kandace Gollomp, 215-590-3535, gollompk@chop.edu
About this study
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.
- Being tested
- Depot medroxyprogesterone acetate (DMPA)
- Keywords
- Sickle Cell Disease, Depot Medroxyprogesterone Acetate (Depo-Provera), Contraception, Vaso-Occlusive Pain
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot medroxyprogesterone acetate (DMPA)Drug
150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
| Study group | Role | What they receive |
|---|---|---|
| Depot Medroxyprogesterone Acetate (Depo-Provera) | Experimental | All participants will receive a 150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension after a 3-month baseline with no hormonal contraception. Receives: Drug: Depot medroxyprogesterone acetate (DMPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute vaso-occlusive episodes
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.
Measured: 6 months
Secondary outcomes (8)
C-reactive protein
C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
Hemoglobin
Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
Reticulocyte count
Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
Platelet count
Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
Fetal hemoglobin
Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
Bilirubin
Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
D-dimer
D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
von Willebrand factor
von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start26 Jun 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Disease (SCD)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Emory University, Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Andrea Roe, MD, MPH, University of Pennsylvania
- Investigators
- Andrea Roe, MD MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665997
- Sponsor's protocol ID
- 857039
- Other IDs
- 1R01HL175726-01
- Acronym
- SCD Depo
- Status last verified
- May 2026
- First submitted
- 23 Oct 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, the de-identified, archived data will be transmitted to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) for use by other researchers including those outside of the study.