Depo-Provera in Women with Sickle Cell Disease
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Description
The goal of this study is to see if women with sickle cell disease (SCD) experience any difference in their pain while using the birth control injection, Depo-Provera, as compared to when not using this method. Depo-Provera is FDA-approved.
The duration of the study is 6 months with 6-7 in-person visits at the University of Pennsylvania that include a urine pregnancy test, blood draw, and surveys. The study duration is divided into a 3-month "baseline" period, where you would not use any hormonal contraception, and 3 months with the Depo-Provera injection. You would also complete weekly messages that ask about pain and menstrual cycle.
We are seeking women who are between the ages of 18 and 50 who have been diagnosed with SCD, have a regular menstrual cycle, and experience at least one vaso-occlusive pain episode per month.
Eligibility and criteria
What to expect
This is a pre-post intervention study with two phases: a 3-month baseline phase during which participants will not use any hormonal contraception, followed by a 3-month interventional phase during which participants will use DMPA. This is an open-label trial where all participants will receive the intervention. The visit schedule is as follows: All the study visits will occur at University of Pennsylvania
Screening Visit 1a
- Obtain consent: Participants will sign the Informed Consent form prior to any screening procedures, and after full review of the ICF (including purpose, procedures risks, benefits, and voluntary nature of study) and after given the opportunity to ask questions.
- After signing the ICF, subjects will undergo the following tests/procedures: Demographic and Medical History collection, Vitals.
Enrollment Visit 1b
- Screening and enrollment are expected to occur on the same day. Enrollment visit should occur on menstrual cycle day 1-5. Adverse event collection, concomitant medication review, and medical record review will take place during enrollment visit if the visits occur on different days.
- Urine pregnancy test, Eligibility confirmation, Collect AEs, Review concomitant medications, Blood tests (Blood tests include cellular blood counts, clinical chemistries, inflammatory cytokines, coagulation markers, sex hormones, and samples for proteomic and microfludic testing, will be performed throughout the study, and anti-Mullerian hormone will be performed once), Text test (Visit 1b marks the starting point of the weekly surveys, and the monthly menses and monthly home pregnancy tests. Study staff will test that the participants can receive and respond to Twilio texts), Surveys, Reporting of pregnancy status and menstruation.
Visit 2, 2-3 weeks after enrollment, based on investigator estimation of luteal phase of menstrual cycle given participant's menstrual history.
- Urine pregnancy test, Collect AEs, Review of concomitant medications, Blood draw, Reporting of recent pain experience
Visit 3, 12 weeks +/- 1 week after enrollment/Visit 1b
- Urine pregnancy test, Collect AEs, Review of concomitant medications, Intervention administration, Reporting of recent sickle cell pain and menstrual pain experience, Completion of Moos MDQ pain subscale for current menstrual cycle, surveys
Visit 4, 4 weeks +/- 1 week after Visit 3
- Urine pregnancy test, Collect AEs, Review of concomitant medications, Blood draw, Reporting of recent sickle cell pain
Visit 5, 4 weeks +/- 1 week after Visit 4
- Urine pregnancy test, Collect AEs, Review of concomitant medications, Blood draw, Reporting of recent pain experience and menstrual pain experience, Completion of Moos MDQ pain subscale for current menstrual cycle, surveys
Visit 6, 12 weeks +/- 1 week after DMPA administration
- Satisfaction assessment: Satisfaction assessment will be conducted by phone or REDCap survey.
Related specialties
Related conditions
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