Depo-Provera (depot medroxyprogesterone acetate) for pain and biomarker changes in women with sickle cell disease
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
This study will test whether an injectable birth control (Depo-Provera) can reduce pain in adult women with sickle cell disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | crizanlizumab |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06665997 on ClinicalTrials.gov |
What this trial studies
Adult women with sickle cell disease who have regular menstrual cycles and frequent vaso-occlusive pain will complete a three-month baseline period without hormonal contraception. Participants will then receive a single injection of depot medroxyprogesterone acetate and be followed for three months to see changes in pain frequency, severity, and blood biomarkers. The protocol includes 6–7 in-person visits for urine pregnancy tests, blood draws, and surveys, plus weekly remote surveys and monthly home pregnancy tests. Study entry requires stable sickle cell medications and willingness to stop other hormonal contraception for the washout period and duration of the study.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–50 with a confirmed sickle cell diagnosis who experience about one or more vaso-occlusive pain episodes per month, have regular 21–35 day menstrual cycles, are on stable sickle cell medications, and are willing to stop other hormonal contraception for the study.
Not a fit: People who are pregnant, breastfeeding, postmenopausal, do not have regular menstrual cycles, are unwilling to stop hormonal contraception, or are male are unlikely to be eligible or to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, Depo-Provera could reduce the number or severity of vaso-occlusive pain episodes and improve quality of life while providing contraception.
How similar studies have performed: There is limited prior evidence on depot medroxyprogesterone in sickle cell disease; small reports exist but effects on pain and biomarkers are not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Female, aged 18-50 years old 3. Diagnosis of sickle cell disease (SS, SB0,SB+,SC) 4. Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months 5. 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 6. 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. 7. Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days. 8. Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months 9. Access to a device with text-messaging capability 10. Must be able to read and understand English 11. Willing to comply with study procedures Exclusion Criteria: 1. Chronic inflammatory conditions, such as lupus or inflammatory bowel disease 2. History of VTE or stroke 3. Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation 4. Current use of hormonal contraception or the copper intrauterine device 5. Current pregnancy or pregnancy within the last 6 months 6. Current lactation 7. Polycystic ovary syndrome or irregular periods 8. Blood pressure \>= 160 systolic or \>=100 diastolic at screening visit 9. 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.
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University — Atlanta, Georgia, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Roe, MD MPH — University of Pennsylvania
- Study coordinator: Arden McAllister, MPH
- Email: arden.mcallister@pennmedicine.upenn.edu
- Phone: 267-785-8044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.