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 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.

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.

Is Depo-Provera generally safe for humans?

Depo-Provera, also known as depot medroxyprogesterone acetate, has been used as a contraceptive for many years and is considered safe for long-term use. Common side effects include changes in menstrual cycles, but it has been shown to have benefits like reducing the risk of certain cancers and improving blood health in people with sickle cell disease. ^{1 2 3 4 5}

How does the drug Depo-Provera differ from other treatments for sickle cell anemia?

Depo-Provera (Depot Medroxyprogesterone Acetate) is unique for sickle cell anemia because it may reduce painful crises and improve blood health by increasing fetal hemoglobin and red blood cell survival, unlike standard treatments that primarily focus on managing symptoms. It is also administered as an injection every 12 weeks, which is different from daily oral medications. ^{1 3 4 6 7}

What data supports the effectiveness of the drug Depot Medroxyprogesterone Acetate for sickle cell anemia?

Research shows that Depot Medroxyprogesterone Acetate can improve blood health in sickle cell anemia patients by increasing fetal hemoglobin and reducing painful crises, which suggests it may help manage the disease. ^{1 3 4 5 6}

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

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

Must be able to read and understand English

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

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+

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. England pubmed.ncbi.nlm.nih.gov

Medroxyprogesterone acetate and homozygous sickle-cell disease. [2019]

2. United States 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. [2013]

3. England pubmed.ncbi.nlm.nih.gov

The feasibility of contraceptive injections at the community pharmacy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Noncontraceptive benefits and therapeutic uses of depot medroxyprogesterone acetate. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Depo-Provera: an injectable contraceptive. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Depot-medroxyprogesterone acetate injection (Depo-Provera): a highly effective contraceptive option with proven long-term safety. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of estrogen replacement therapy in long-term users of depot medroxyprogesterone acetate. [2016]