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Hormone Therapy

Depo-Provera for Sickle Cell Anemia (SCD Depo Trial)

Phase 4

Waitlist Available

Led By Andrea Roe, MD MPH

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of sickle cell disease (SS, SB0, SB+, SC)

At least 1 and no more than 10 medical presentations (e.g. hospitalization, emergency room visit, outpatient infusion visit) for sickle cell-related pain during the past year

Must not have

Current use of hormonal contraception or the copper intrauterine device

Polycystic ovary syndrome or irregular periods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

"This trial aims to determine if using a birth control shot, Depo-Provera, can help reduce pain in women with sickle cell disease. Adult women with sickle cell disease who often experience

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Depo-Provera include menstrual changes, weight gain, headaches, abdominal discomfort, dizziness, decreased bone density over time, mood swings, or other hormone-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with sickle cell disease.

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

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I am a woman aged between 18 and 50.

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I have had at least one pain crisis a month for the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have polycystic ovary syndrome or irregular menstrual cycles.

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I have had a blood clot or stroke in the past.

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I am currently using crizanlizumab, voxelotor, or undergoing red cell exchange transfusion, or I have had a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of acute vaso-occlusive episodes

Secondary study objectives

Bilirubin

C-reactive protein

D-dimer

+5 more

Side effects data

From 2019 Phase 4 trial • 59 Patients • NCT02357368

Extended menstrual bleeding with blood clots

100%

80%

60%

40%

20%

Study treatment Arm

Levonorgestrel Intrauterine Device (Lng-IUD)

Etonogestrel Impant (Eng-Implant)

ParaGard® T 380A Intrauterine Copper Contraceptive

Depot Medroxyprogesterone Acetate (DMPA)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Depot Medroxyprogesterone Acetate (Depo-Provera)Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Depot medroxyprogesterone acetate (DMPA)

2018

Completed Phase 4

~250

0 / 8Eligibility criteria met