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Intrauterine Device

Copper IUD for Mucositis (UMPALA Trial)

Phase 4
Waitlist Available
Led By Andrea Thurman
Research Sponsored by Eastern Virginia Medical School
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 50 years, inclusive
Willing to give voluntary consent and sign an informed consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks and 3 months after product use
Awards & highlights

UMPALA Trial Summary

This trial looks at the effect of four different contraceptives on the cervical and vaginal tissues, as well as on factors in the blood.

Eligible Conditions
  • Mucositis
  • Intrauterine Contraception Complications

UMPALA Trial Eligibility Criteria

Inclusion Criteria

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

UMPALA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks and 3 months after product use
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks and 3 months after product use for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with changes to mucosal function
Number of participants with changes to mucosal health
Secondary outcome measures
Number of participants with systemic inflammation
Other outcome measures
Mucosal susceptibility to pathogens

UMPALA Trial Design

4Treatment groups
Active Control
Group I: Copper IUDActive Control1 Intervention
The copper IUD contains approximately 176 mg of copper wire wrapped around a vertical stem. It is FDA approved for pregnancy prevention for 10 years.
Group II: Etonogestrel ImplantActive Control1 Intervention
The ETG implant is a single, radiopaque, rod shaped implant containing 68 mg of etonogestrel. It is FDA approved for pregnancy prevention for 3 years.
Group III: Levonorgestrel IUSActive Control1 Intervention
The LNG IUS contains approximately 52 mg. of LNG. It is FDA approved for pregnancy prevention for 5 - 6 years.
Group IV: DMPA Sub-cutaneousActive Control1 Intervention
DMPA contains 104 mg of medroxyprogesterone acetate in 0.65 mL of fluid, administered by subcutaneous injection in the abdominal fat, thigh or skin over the deltoid muscle. It is FDA approved for pregnancy prevention for 14 weeks.

Find a Location

Who is running the clinical trial?

Eastern Virginia Medical SchoolLead Sponsor
68 Previous Clinical Trials
10,286 Total Patients Enrolled
CONRADOTHER
58 Previous Clinical Trials
11,501 Total Patients Enrolled
1 Trials studying Mucositis
20 Patients Enrolled for Mucositis
Kenya Medical Research InstituteOTHER
170 Previous Clinical Trials
1,380,070 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~28 spots leftby Mar 2025