Depo-Provera for Sickle Cell Anemia

(SCD Depo Trial)

Recruiting at 3 trial locations

Overseen By Arden McAllister, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Pennsylvania

Must not be taking: Crizanlizumab, Voxelotor, Hormonal contraception

Disqualifiers: Chronic inflammatory conditions, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an injectable birth control called Depo-Provera can reduce pain in women with sickle cell disease. Sickle cell disease often causes painful episodes, and researchers seek to assess whether this treatment can make a difference. Women with sickle cell disease who regularly experience these painful episodes might be suitable for this study. Participants will first undergo a period without hormonal contraception, then receive the Depo-Provera shot, followed by several follow-up visits and surveys to track changes in pain levels. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

You will need to stop using any hormonal contraception before joining the study. There is a required washout period of 1 month since last use of all hormonal contraception, and 4 months since the last use of depot medroxyprogesterone. However, you can continue taking your stable dose of sickle cell-related medications.

What is the safety track record for this treatment?

Research has shown that Depo-Provera, a type of birth control, is safe for women with sickle cell disease. It effectively prevents pregnancy without increasing the risk of blood clots, a concern with some other contraceptives. Additionally, it may help reduce pain for women with sickle cell disease. Overall, studies suggest that Depo-Provera is well-tolerated, making it a suitable option for those in this trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for sickle cell anemia, which typically focus on managing pain and preventing complications, Depot Medroxyprogesterone Acetate (DMPA) is being explored for its potential to address the condition through hormonal regulation. Researchers are excited about this approach because DMPA is a long-acting injectable contraceptive that could offer a novel way to influence certain bodily processes that might benefit individuals with sickle cell anemia. This treatment is unique in its delivery method—a 150mg dose administered intramuscularly—which provides sustained release and could potentially reduce the frequency of interventions needed compared to current daily medications.

What evidence suggests that Depo-Provera might be an effective treatment for sickle cell pain?

Research has shown that Depo-Provera, a medication often used for birth control, can improve blood health in people with sickle cell anemia. It increases fetal hemoglobin, which helps reduce the number of sickle cell crises. Studies have also found that Depo-Provera is safe for women with sickle cell disease and may lessen sickle cell pain. While primarily used as a contraceptive, its positive effects on blood health offer hope for additional benefits in managing sickle cell symptoms. In this trial, all participants will receive a 150mg dose of depot medroxyprogesterone acetate (DMPA) to evaluate its impact on sickle cell anemia. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrea Roe, MD MPH

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Adult women with sickle cell disease who often have pain from their condition can join this study. They must not be using hormonal contraception during the initial 3-month baseline period and should be willing to receive Depo-Provera injections and complete various tests and surveys.

Inclusion Criteria

Must be able to read and understand English

I've had 1 to 10 hospital visits for sickle cell pain in the last year.

I agree to stop using hormonal birth control and have followed the required waiting period.

Exclusion Criteria

Current pregnancy or pregnancy within the last 6 months

Current lactation

I am currently using hormonal birth control or a copper IUD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a 3-month baseline with no use of hormonal contraception

12 weeks

3-4 visits (in-person), weekly remote surveys

Treatment

Participants receive a 150mg dose of Depot Medroxyprogesterone Acetate (Depo-Provera) and are monitored for effects

12 weeks

3-4 visits (in-person), weekly remote surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Depot Medroxyprogesterone Acetate

Trial Overview The trial is testing if Depot Medroxyprogesterone Acetate (Depo-Provera), an injectable contraceptive, can lessen pain in women with sickle cell disease. It involves a comparison between a 3-month period without hormonal contraception and a subsequent 3-month period after receiving the injection.

How Is the Trial Designed?

Group I: Depot Medroxyprogesterone Acetate (Depo-Provera) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

Depot medroxyprogesterone acetate (DMPA) use is linked to a 5% reduction in bone density at the lumbar spine and hip in women who start using it before age 20, indicating potential risks for younger users.

The study found that DMPA affects bone health primarily through estrogen deficiency, as it was associated with lower estradiol levels and increased bone turnover in both younger and older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Depot medroxyprogesterone acetate on bone density and bone metabolism before and after peak bone mass: a case-control study. Walsh, JS., Eastell, R., Peel, NF.[2013]

A pilot study involving 50 women showed that while the subcutaneous contraceptive injection (Sayana Press®) could be administered by pharmacists in community pharmacies, only 34% of the potential injections were delivered, indicating challenges in recruitment and retention.

Participants had mixed experiences with the service, highlighting the need for more trained pharmacists to ensure consistent availability and improve the feasibility of this contraceptive delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of contraceptive injections at the community pharmacy. Heller, R., Johnstone, A., Cameron, ST.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8923261/

Steroid hormones for contraception in women with sickle cell ... The limited available data suggest that DMPA is a safe contraceptive option for women in SS disease. There is not enough evidence to fully understand the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06665997

NCT06665997 | Clinical and Biomarker Effects of Depot ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S247395292300455X

Comparison of thromboembolism outcomes in patients with ... The most commonly prescribed contraceptives in publicly insured patients with SCD are combination pills and depot medroxyprogesterone acetate. •.

4. withpower.com withpower.com/trial/phase-4-sickle-cell-disease-scd-11-2024-58800

Depo-Provera for Sickle Cell Anemia (SCD Depo Trial) Research shows that Depot Medroxyprogesterone Acetate can improve blood health in sickle cell anemia patients by increasing fetal hemoglobin and reducing ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8725704/

Depot medroxyprogesterone acetate contraception in ... DMPA also is safe in women with sickle cell disease and actually has been shown to reduce the incidence of sickle cell crisis. Evidence also suggests that ...

6. reproductiveaccess.org reproductiveaccess.org/resource/contraception-and-sickle-cell-disease/

Contraception and Sickle Cell Disease SCD can carry an increased risk of complications with pregnancy (eg increased frequency of sickle cell pain crises, acute anemia, chronic organ damage)

7. cdc.gov cdc.gov/contraception/hcp/usmec/progestin-only-contraceptives.html

Appendix C: Classifications for Progestin-Only ... Effects of depot medroxyprogesterone acetate injection timing on medical abortion efficacy and repeat pregnancy: a randomized controlled trial.