Clinical trial for Sickle Cell Disease (SCD)
Official title Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
ClinicalTrials.gov ID: NCT06665997
What this study is testing
What is Depot medroxyprogesterone acetate (DMPA)?
An investigational injectable hormone being studied to see if it can reduce pain in women with sickle cell disease. It is designed to release a progestin hormone that suppresses ovulation and reduces menstrual bleeding.
Also referred to as Depo-Provera.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether an injectable contraceptive can lower the frequency or severity of sickle cell pain episodes.
- Who it's for
- Adult women who have sickle cell disease and regularly experience pain episodes.
- What's involved
- Participants will have a 3‑month period without hormonal birth control, then receive a Depo-Provera injection and be followed for another 3 months. They will attend 6‑7 clinic visits for urine pregnancy tests, blood draws, and surveys, plus weekly online surveys and monthly home pregnancy tests.
- Time commitment
- The trial lasts about 6 months with several in‑person visits and regular remote surveys.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
- Current use of hormonal contraception or the copper intrauterine device
- Current pregnancy or pregnancy within the last 6 months
- Current lactation
See the full eligibility 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...
- 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
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.