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Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient


Phase 4
18 Years
50 Years
Open (Enrolling)
Female
Dysfunctional Uterine Bleeding

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Trial Information

Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient


Inclusion Criteria:



- Women 18- 50

- Non-pregnant

- Candidate for outpatient management

- Able to understand and follow instructions

- Vital signs stable

- No severe anemia

- No medical conditions requiring transfusion

Exclusion Criteria:

- Pregnancy

- Breast cancer current or in last 5 years

- Allergy to MPA or DMPA

- Previous hormonal therapies

- Unstable vital signs

- Bleeding excessive enough to require surgical therapy or hospital admission

- Desire for pregnancy in next 6 months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Slowing of acute bleeding.

Outcome Time Frame:

24-28 hours

Safety Issue:

Yes

Principal Investigator

Anita L. Nelson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

United States: Institutional Review Board

Study ID:

13530-01

NCT ID:

NCT01148420

Start Date:

January 2009

Completion Date:

October 2010

Related Keywords:

  • Dysfunctional Uterine Bleeding
  • Hemorrhage
  • Metrorrhagia
  • Uterine Hemorrhage

Name

Location

Harbor-UCLA Urgent CareTorrance, California  90502